510(k) · Cleared
Recalled · 2007Abrm Catheter
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 Feb 8, 1996 after a 393-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 15 of the 135 devices in its family, counting itself, have a Class I recall. 134 later devices descend from it. It has been recalled once.
- Decided
- Feb 8, 1996
- Review
- 393 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- 1
- Predicates
- 0
134 later devices descend from it, 2 citing it directly. 15 of the 135 devices in this family, counting this one, have a Class I recall.
- This deviceK950118 Abrm CatheterCook, Inc. · 1996
- Descendant · cites it directly · 126 of its ownK021557 Spectrum Silicone CatheterCook, Inc. · 2003
- Descendant · 2 generations on · 119 of its ownK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- Descendant · 3 generations on · 66 of its ownK070996 4 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc. · 2007
- Descendant · 3 generations on · 47 of its ownK061179 Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc. · 2006
- Descendant · cites it directly · 33 of its ownK033843 Spectrum Central Venous Catheter with or Without Hydrophilic CoatingCook, Inc. · 2004 · Recalled
Showing 5 of 134 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 134 · See all- K021557Spectrum Silicone CatheterCook, Inc. · 2003 · cites it directly126descendants
- K051991Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power LineC.R. Bard, Inc. · 2005 · 2 generations on119descendants
- K0709964 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc. · 2007 · 3 generations on66descendants
- K061179Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc. · 2006 · 3 generations on47descendants
- K033843Spectrum Central Venous Catheter with or Without Hydrophilic CoatingCook, Inc. · 2004 · cites it directly33descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K950118 | Abrm Catheter | Cook, Inc. | 1996 | — |
| +1 | K021557 | Spectrum Silicone Catheter | Cook, Inc. | 2003 | — |
| +2 | K051991 | Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line | C.R. Bard, Inc. | 2005 | — |
| +3 | K070996 | 4 FR Single Lumen (SL) Powerpicc Catheter | C.R. Bard, Inc. | 2007 | — |
| +3 | K061179 | Powerhickman Long-Term Intravascular Catheter | C.R. Bard, Inc. | 2006 | — |
| +1 | K033843 | Spectrum Central Venous Catheter with or Without Hydrophilic Coating | Cook, Inc. | 2004 | 10 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 1 |
| 2008 | 3 | 0 |
| 2009 | 6 | 0 |
| 2010 | 7 | 1 |
| 2011 | 5 | 0 |
| 2012 | 16 | 3 |
| 2013 | 14 | 2 |
| 2014 | 13 | 2 |
| 2015 | 7 | 2 |
| 2016 | 13 | 2 |
| 2017 | 4 | 0 |
| 2018 | 9 | 0 |
| 2019 | 5 | 0 |
| 2020 | 6 | 0 |
| 2021 | 1 | 1 |
| 2022 | 3 | 1 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 6 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
15 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (134)
See all 1342 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (15 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 2, 2007 | Not classified | Z-0637-2007 | Other | These catheters do not include the proximal sidehole as required by the specification. |
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.
- K071538Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous CatheterArrow International, Inc. · 2007 · 4 generations on · ◆ in the 2007 descendants bar of FIG. 15 Class I recalls
- K210264BD PowerPiCC CatheterBard Access Systems, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K113277Arrowadvantages Pressure Injectable Peripherally Inscrted Central Catheter KitsArrow International, Inc. · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K143102Multi-Lumen Acute Hemodialysis Catheter for High Volume InfusionsArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2015 · 4 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
- K133456Power-Trialysis Short-Term Dialysis CatheterC.R. Bard, Inc. · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
- K102605Mahurkar Triple Lumen Dialysis CatheterCovidien, LLC, Formerly Registered AS Tyco Healthca · 2010 · 4 generations on · ◆ in the 2010 descendants bar of FIG. 125 Class I recalls
- K112896Arrw EvolutionArrow International (Subsidiary of Teleflex Inc.) · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K131260Nmi Dialysis CatheterNavilyst Medical, Inc. · 2014 · 5 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
- K141531Power-Trialysis Slim-Cath Short-Term Dialysis CatheterC.R. Bard, Inc. · 2015 · 5 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
- K122545CG+ Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2012 · 6 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K132133CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2013 · 6 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K130876CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. · 2013 · 7 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
Nearest 12 of 15 shown.
Nearest 5 of 15; all are on the web page.
What does this lineage say?
- Of its descendants, K021557 (Cook, Inc., 2003) has gone furthest, with 126 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K950118 · printed Nov 5, 2026
Cite this page
510(k) Report. “K950118: Abrm Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K950118
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026