510(k) · Cleared
Recalled · Class II · 2026Cook and Cook Spectrum Central Venous Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook, Inc. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Jul 30, 2008 as substantially equivalent to K033843 (Cook, Inc., 2004) and 2 other predicates after a 103-day review. Its family tree reaches back 4 generations to 1997. 1 of the 41 devices in its family, counting itself, has a Class I recall. 31 later devices descend from it. It has been recalled 105 times.
- Decided
- Jul 30, 2008
- Review
- 103 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- 105
- Predicates
- 3
Its longest line of descent runs back 4 generations to K960764 (1997). 9 ancestors in all, the oldest K904404 (1991). 31 later devices descend from it, 3 citing it directly. 1 of the 41 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK960764 Safe-CathScientific Device Manufacturer, LLC · 1997
- 3 generations backK984189 Argon Multi-Lumen Central Venous CatheterMaxxim Medical · 1999
- 2 generations backK032274 Cook Five Lumen Central Venous CatheterCook, Inc. · 2004
- 1 generation backK060174 Spectrum Five Lumen Central Venous Catheter Set, Model C-UQLM10.0-AbrmCook, Inc. · 2006
- This deviceK081113 Cook and Cook Spectrum Central Venous CathetersCook, Inc. · 2008
- Descendant · cites it directly · 26 of its ownK101326 NMI ICNavilyst Medical, Inc. · 2010
- Descendant · 2 generations on · 23 of its ownK121089 Nmi Picc IiiNavilyst Medical, Inc. · 2012
- Descendant · 2 generations on · 14 of its ownK111906 Xcela Hybrid Picc with Pasv Valve TechnologyNavilyst Medical, Inc. · 2011
- Descendant · 3 generations on · 12 of its ownK122882 Nmi Hpicc IiiNavilyst Medical, Inc. · 2012
- Descendant · 3 generations on · 7 of its ownK131942 Nmi Picc Iii Catheter, Nmi Hpicc Iii CatheterNavilyst Medical, Inc. · 2013
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
2010high 5 (2015) · low 0 (2021)2026
Class I recalls in this family
- K131260 Nmi Dialysis Catheter3 generations on · 2014
Most influential descendants
Showing 5 of 31 · See all- K101326NMI ICNavilyst Medical, Inc. · 2010 · cites it directly26descendants
- K121089Nmi Picc IiiNavilyst Medical, Inc. · 2012 · 2 generations on23descendants
- K111906Xcela Hybrid Picc with Pasv Valve TechnologyNavilyst Medical, Inc. · 2011 · 2 generations on14descendants
- K122882Nmi Hpicc IiiNavilyst Medical, Inc. · 2012 · 3 generations on12descendants
- K131942Nmi Picc Iii Catheter, Nmi Hpicc Iii CatheterNavilyst Medical, Inc. · 2013 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K960764 | Safe-Cath | Scientific Device Manufacturer, LLC | 1997 | — |
| −3 | K984189 | Argon Multi-Lumen Central Venous Catheter | Maxxim Medical | 1999 | — |
| −2 | K032274 | Cook Five Lumen Central Venous Catheter | Cook, Inc. | 2004 | — |
| −1 | K060174 | Spectrum Five Lumen Central Venous Catheter Set, Model C-UQLM10.0-Abrm | Cook, Inc. | 2006 | — |
| 0 (this device) | K081113 | Cook and Cook Spectrum Central Venous Catheters | Cook, Inc. | 2008 | — |
| +1 | K101326 | NMI IC | Navilyst Medical, Inc. | 2010 | — |
| +2 | K121089 | Nmi Picc Iii | Navilyst Medical, Inc. | 2012 | — |
| +2 | K111906 | Xcela Hybrid Picc with Pasv Valve Technology | Navilyst Medical, Inc. | 2011 | — |
| +3 | K122882 | Nmi Hpicc Iii | Navilyst Medical, Inc. | 2012 | — |
| +3 | K131942 | Nmi Picc Iii Catheter, Nmi Hpicc Iii Catheter | Navilyst Medical, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 3 | 1 |
| 2015 | 5 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FOZ device
- #1 K243403 BD Nexiva™ Closed IV Catheter Systemscore 14.8 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K033843 | Spectrum Central Venous Catheter with or Without Hydrophilic CoatingSummary page 1…d indications for use statement are substantially equivalent to the Spectrum Central Venous Catheters with or without Hydrophilic Coating cleared under FDA 510(k) number K033843, the Five Lumen Central Venous Catheter cleared under 510(k) number K032274, and the Spectrum Five Lumen Central Venous Catheter… | 2004 |
| * | K032274 | Cook Five Lumen Central Venous CatheterSummary page 1…Central Venous Catheters with or without Hydrophilic Coating cleared under FDA 510(k) number K033843, the Five Lumen Central Venous Catheter cleared under 510(k) number K032274, and the Spectrum Five Lumen Central Venous Catheter cleared under 5 10(k) number K060174. They are similar to the Cook Incorpora… | 2004 |
| * | K060174 | Spectrum Five Lumen Central Venous Catheter Set, Model C-UQLM10.0-AbrmSummary page 1…ber K033843, the Five Lumen Central Venous Catheter cleared under 510(k) number K032274, and the Spectrum Five Lumen Central Venous Catheter cleared under 5 10(k) number K060174. They are similar to the Cook Incorporated Central Venous Catheters marketed prior to 1976. Cook Incorporated-Jul… | 2006 |
What descends from it? (31)
See all 313 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 5, 2026 | Class II | Z-1783-2026 | Incorrect or no expiration date | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| Mar 5, 2026 | Class II | Z-1789-2026 | Incorrect or no expiration date | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| Mar 5, 2026 | Class II | Z-1788-2026 | Incorrect or no expiration date | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| Oct 4, 2010 | Not classified | Z-1198-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1123-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1099-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1112-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1119-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1153-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1212-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1173-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1166-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1201-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1216-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1171-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1163-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1131-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1205-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1152-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1154-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1125-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1098-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1180-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1194-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1127-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1203-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1169-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1151-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1164-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1137-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1196-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1142-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1211-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1105-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1147-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1174-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1149-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1114-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1110-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1145-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1141-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1214-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1162-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1202-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1161-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1192-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1159-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1111-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1155-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
| Oct 4, 2010 | Not classified | Z-1121-2011 | Nonconforming Material/Component | Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection… |
The 5 latest of 50 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K131260Nmi Dialysis CatheterNavilyst Medical, Inc. · 2014 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 3 of the 9 ancestors have a recall of any class.
- Of its descendants, K101326 (Navilyst Medical, Inc., 2010) has gone furthest, with 26 descendants of its own.
- 1 other device also cites its predicate K033843.
How does its category compare?
All FOZ devicesFOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · FOZ
11in 2025
2007high 13 (2012) · low 1 (2018)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · FOZ
91in 2025
2007high 242 (2021) · low 28 (2010)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FOZ
4in 2023
2007high 115 (2010) · low 0 (2008)2026
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · FOZ
5,110in 2025
2007high 5,110 (2025) · low 370 (2010)2025
MAUDE reports naming product code FOZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 159 | 16 | 374 |
| 2008 | 9 | 103 | 0 | 422 |
| 2009 | 9 | 30 | 23 | 508 |
| 2010 | 3 | 28 | 115 | 370 |
| 2011 | 6 | 132 | 0 | 786 |
| 2012 | 13 | 122 | 0 | 560 |
| 2013 | 4 | 104 | 2 | 640 |
| 2014 | 9 | 99 | 4 | 815 |
| 2015 | 10 | 107 | 0 | 729 |
| 2016 | 9 | 63 | 3 (1) | 925 |
| 2017 | 9 | 51 | 22 | 1,966 |
| 2018 | 1 | — | 4 | 3,305 |
| 2019 | 8 | 140 | 3 | 4,365 |
| 2020 | 10 | 191 | 3 | 3,797 |
| 2021 | 4 | 242 | 1 | 4,674 |
| 2022 | 8 | 183 | 4 (2) | 4,133 |
| 2023 | 9 | 129 | 4 (2) | 4,430 |
| 2024 | 6 | 190 | 0 | 4,772 |
| 2025 | 11 | 91 | 0 | 5,110 |
| 2026 | 7 | 203 | 2 | — |
What is it indicated for?
The Cook Central Venous Catheter is used for: * Continuous or intermittent drug infusions * Central venous blood pressure monitoring (CVP) * Acute hyperalimentation * Blood sampling * Delivery of whole blood or blood products * Power injection of contrast media* The device is a short-term use catheter. * The flow rate of the Cook Central Venous Catheters may not exceed 10 ml/sec. The Cook Spectrum and Spectrum Glide Central Venous Catheter is used for: *…
Read the full statement (167 words)
The Cook Central Venous Catheter is used for:
* Continuous or intermittent drug infusions
* Central venous blood pressure monitoring (CVP)
* Acute hyperalimentation
* Blood sampling
* Delivery of whole blood or blood products
* Power injection of contrast media*
The device is a short-term use catheter.
* The flow rate of the Cook Central Venous Catheters may not exceed 10 ml/sec.
The Cook Spectrum and Spectrum Glide Central Venous Catheter is used for:
* Continuous or intermittent drug infusions
* Central venous blood pressure monitoring (CVP)
* Acute hyperalimentation
* Blood sampling
* Delivery of whole blood or blood products
* Power injection of contrast media*
The activity of the antimicrobial agents, minocycline and rifampin, is localized at the internal and external catheter surface and helps to provide protection against catheter-related bloodstream infections (CRBSI). It is not intended for treatment of existing infection. The device is a short-term use catheter.
* The flow rate of the Cook Central Venous Catheters may not exceed 10 ml/sec.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081113 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081113: Cook and Cook Spectrum Central Venous Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081113
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026