510(k) · Cleared
Recalled · 2008Vamp Venous/Arterial Blood Management Protection
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · KRA Catheter, Continuous Flush
Cleared on Mar 3, 1989 after a 66-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it. It has been recalled once.
- Decided
- Mar 3, 1989
- Review
- 66 days
- Class
- Class II
- Product code
- KRA
- Recalls
- 1
- Predicates
- 0
9 later devices descend from it, 4 citing it directly.
- This deviceK885281 Vamp Venous/Arterial Blood Management ProtectionBaxter Healthcare Corp · 1989
- Descendant · cites it directly · 3 of its ownK161962 VAMP Venous/Arterial Blood Management Protection SystemEdwards Lifesciences, LLC · 2016 · Recalled
- Descendant · cites it directly · 2 of its ownK163172 HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer…Smiths Medical Asd, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK173586 VAMP Venous/Arterial Blood Management Protection SystemEdwards Lifesciences, LLC · 2018
- Descendant · 2 generations on · 1 of its ownK172458 HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer…Smiths Medical Asd, Inc. · 2017
- Descendant · 3 generations on · 0 of its ownK221782 Meritrans ECO Reusable Pressure Transducer, Meritrans ECO DomesMerit Medical Pte., Ltd. · 2023
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K161962VAMP Venous/Arterial Blood Management Protection SystemEdwards Lifesciences, LLC · 2016 · cites it directly3descendants
- K163172HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus…Smiths Medical Asd, Inc. · 2017 · cites it directly2descendants
- K173586VAMP Venous/Arterial Blood Management Protection SystemEdwards Lifesciences, LLC · 2018 · 2 generations on1descendant
- K172458HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus…Smiths Medical Asd, Inc. · 2017 · 2 generations on1descendant
- K221782Meritrans ECO Reusable Pressure Transducer, Meritrans ECO DomesMerit Medical Pte., Ltd. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K885281 | Vamp Venous/Arterial Blood Management Protection | Baxter Healthcare Corp | 1989 | — |
| +1 | K161962 | VAMP Venous/Arterial Blood Management Protection System | Edwards Lifesciences, LLC | 2016 | 8 |
| +1 | K163172 | HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit… | Smiths Medical Asd, Inc. | 2017 | — |
| +2 | K173586 | VAMP Venous/Arterial Blood Management Protection System | Edwards Lifesciences, LLC | 2018 | — |
| +2 | K172458 | HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit… | Smiths Medical Asd, Inc. | 2017 | — |
| +3 | K221782 | Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes | Merit Medical Pte., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2023 | 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.
Planning a device in KRA? 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 KRA device
- #1 K253509 TriSalus TriNav Advance Infusion Systemscore 14.4 · 9 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? (9)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161962 | VAMP Venous/Arterial Blood Management Protection System | 2016 | 3 |
| K163172 | HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus… | 2017 | 2 |
| K983372 | Bioport Closed Blood Sampling System, Model BT Xxxxxx- BP | 1999 | 0 |
| K955663 | Abc in-Line Blood Sampling Kit | 1997 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 14, 2008 | Not classified | Z-1934-2009 | Equipment maintenance | Edwards Lifescience initiated a recall of on Edwards "VAMP Jr" Pressure Monitoring Products manufactured between 8/01/06 and 2/29/08 due to the potential for the cap on the reservoir of the "VAMP Jr" to become disconnected. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K161962 (Edwards Lifesciences, LLC, 2016) has gone furthest, with 3 descendants of its own.
How does its category compare?
All KRA devicesKRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KRA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KRA
63in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRA
41so far in 2026, the most since 2007
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · KRA
980in 2025
MAUDE reports naming product code KRA, 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 | 5 | 44 | 2 | 118 |
| 2008 | 7 | 144 | 6 | 117 |
| 2009 | 5 | 69 | 8 | 187 |
| 2010 | 2 | — | 26 | 355 |
| 2011 | 2 | — | 3 | 239 |
| 2012 | 3 | 29 | 3 | 217 |
| 2013 | 3 | 126 | 2 | 209 |
| 2014 | 4 | 61 | 3 (2) | 276 |
| 2015 | 0 | — | 1 | 339 |
| 2016 | 8 | 122 | 3 (1) | 418 |
| 2017 | 4 | 166 | 0 | 538 |
| 2018 | 4 | 178 | 0 | 434 |
| 2019 | 4 | 133 | 4 (4) | 418 |
| 2020 | 6 | 29 | 1 | 381 |
| 2021 | 6 | 108 | 0 | 440 |
| 2022 | 6 | 228 | 0 | 543 |
| 2023 | 7 | 63 | 2 | 829 |
| 2024 | 0 | — | 0 | 942 |
| 2025 | 1 | — | 0 | 980 |
| 2026 | 5 | 268 | 41 | — |
https://510kreport.com/device/K885281 · printed Nov 6, 2026
Cite this page
510(k) Report. “K885281: Vamp Venous/Arterial Blood Management Protection.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K885281
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026