510(k) · Cleared
ClearedSpectrum Turbo-Ject Picc Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on May 6, 2010 as substantially equivalent to K081690 (Cook, Inc., 2008) after a 28-day review. Its family tree reaches back 4 generations to 1986. 2 of the 13 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.
- Decided
- May 6, 2010
- Review
- 28 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K862056 (1986). 10 ancestors in all. 2 later devices descend from it, 1 citing it directly. 2 of the 13 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK862056 [Central Venous][Multi-Lumen] Catheter W/Flex TipArrow Intl., Inc. · 1986 · Recalled (Class I)
- 3 generations backK992198 Urethane Picc Line Model Upics-Cook, Inc. · 1999
- 2 generations backK021557 Spectrum Silicone CatheterCook, Inc. · 2003
- 1 generation backK081690 Spectrum Turbo-Ject Peripherally Inserted Central Venous CatheterCook, Inc. · 2008
- This deviceK100974 Spectrum Turbo-Ject Picc SetCook Incorporated · 2010
- Descendant · cites it directly · 1 of its ownK111244 Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc)Cook, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK141818 Turbo-Ject Picc SetsCook Corporated · 2014
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K862056 | [Central Venous][Multi-Lumen] Catheter W/Flex Tip | Arrow Intl., Inc. | 1986 | Class I |
| −3 | K992198 | Urethane Picc Line Model Upics- | Cook, Inc. | 1999 | — |
| −2 | K021557 | Spectrum Silicone Catheter | Cook, Inc. | 2003 | — |
| −1 | K081690 | Spectrum Turbo-Ject Peripherally Inserted Central Venous Catheter | Cook, Inc. | 2008 | — |
| 0 (this device) | K100974 | Spectrum Turbo-Ject Picc Set | Cook Incorporated | 2010 | — |
| +1 | K111244 | Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc) | Cook, Inc. | 2011 | — |
| +2 | K141818 | Turbo-Ject Picc Sets | Cook Corporated | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 2 | 1 |
| 2001 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 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.
2 devices in this family have 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? (1)
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 |
|---|---|---|---|
| * | K081690 | Spectrum Turbo-Ject Peripherally Inserted Central Venous CatheterSummary page 2….... 07 April 2010 Predicate Devices: SpectrumV) Turbo-JeC7Um PICC Set, 510(k) number KO081690 Device Description: The Spectrum Turbo-JeCT PICC catheters are radiopaque polyurethane peripherally inserted central venous ca… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111244 | Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc) | 2011 | 1 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
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.
- K993691Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 2000 · 3 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K862056[Central Venous][Multi-Lumen] Catheter W/Flex TipArrow Intl., Inc. · 1986 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- 5 of the 10 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K111244 (Cook, Inc., 2011) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K081690.
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. 2010, this device’s year, is highlighted.
FDA decisions per year · FOZ
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FOZ
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FOZ
4in 2023
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · FOZ
5,110in 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 Spectrum Turbo-JeCT PICC is indicated for short- or long-term use for venous pressure monitoring, blood sampling, administration of drugs and fluids, and for use with power injectors for delivery of contrast in CT studies. The catheter is impregnated with the antimicrobials minocycline and rifampin to help provide protection against catheter-related bloodstream infections (CRBSIs). The Spectrum Turbo-JeCT PICC is indicated for multiple injections of…
Read the full statement (228 words)
The Spectrum Turbo-JeCT PICC is indicated for short- or long-term use for venous pressure monitoring, blood sampling, administration of drugs and fluids, and for use with power injectors for delivery of contrast in CT studies. The catheter is impregnated with the antimicrobials minocycline and rifampin to help provide protection against catheter-related bloodstream infections (CRBSIs). The Spectrum Turbo-JeCT PICC is indicated for multiple injections of contrast media through a power injector. The maximum pressure limit setting for power injectors used with the Spectrum Turbo-JeCT PICC may not exceed 325 psi and the flow rate may not exceed the maximum flow rate indicated.
Catheter Size — Maximum Flow Rate* — Injection Pressure Limit Setting
3 Fr Single Lumen — 2 mL/sec — 325 psi
4 Fr Single Lumen — 4 mL/sec — 325 psi
5 Fr Single Lumen — 7 mL/sec — 325 psi
5 Fr Double Lumen — 5 mL/sec — 325 psi
6 Fr Triple Lumen** — 7 mL/sec — 325 psi
*Flow rates achieved using room temperature Omnipaque 300® contrast and verified using a Medrad Stellant® CT injector system. Omnipaque 300 has a viscosity of 11.8 centipoise at room temperature (20 degrees C). A change in temperature or viscosity of the contrast medium used will result in a change in achievable flow rates.
**Lumen #1 only.
Omnipaque 300® is a registered trademark of Amersham Health, New Jersey.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100974 · printed Nov 5, 2026
Cite this page
510(k) Report. “K100974: Spectrum Turbo-Ject Picc Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K100974
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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