510(k) · Cleared
Recalled · Class II · 2021VAMP Venous/Arterial Blood Management Protection System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences, LLC · KRA Catheter, Continuous Flush
Cleared on Nov 28, 2016 as substantially equivalent to K885281 (Baxter Healthcare Corp, 1989) after a 133-day review. Its family tree reaches back 1 generation to 1989. 3 later devices descend from it. It has been recalled 8 times.
- Decided
- Nov 28, 2016
- Review
- 133 days
- Class
- Class II
- Product code
- KRA
- Recalls
- 8
- Predicates
- 1
Its longest line of descent runs back 1 generation to K885281 (1989). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK885281 Vamp Venous/Arterial Blood Management ProtectionBaxter Healthcare Corp · 1989 · Recalled
- This deviceK161962 VAMP Venous/Arterial Blood Management Protection SystemEdwards Lifesciences, LLC · 2016
- Descendant · cites it directly · 1 of its ownK173586 VAMP Venous/Arterial Blood Management Protection SystemEdwards Lifesciences, LLC · 2018
- Descendant · cites it directly · 0 of its ownK181684 VAMP Plus Venous/Arterial Blood Management Protection SystemEdwards Lifesciences, LLC · 2018 · Recalled
- Descendant · cites it directly · 0 of its ownK180275 VAMP Optima closed blood sampling systemEdwards Lifesciences, LLC · 2018
Most influential descendants
Showing 3 of 3 · See all- K173586VAMP Venous/Arterial Blood Management Protection SystemEdwards Lifesciences, LLC · 2018 · cites it directly1descendant
- K181684VAMP Plus Venous/Arterial Blood Management Protection SystemEdwards Lifesciences, LLC · 2018 · cites it directly0descendants
- K180275VAMP Optima closed blood sampling systemEdwards Lifesciences, LLC · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K885281 | Vamp Venous/Arterial Blood Management Protection | Baxter Healthcare Corp | 1989 | 1 |
| 0 (this device) | K161962 | VAMP Venous/Arterial Blood Management Protection System | Edwards Lifesciences, LLC | 2016 | — |
| +1 | K173586 | VAMP Venous/Arterial Blood Management Protection System | Edwards Lifesciences, LLC | 2018 | — |
| +1 | K181684 | VAMP Plus Venous/Arterial Blood Management Protection System | Edwards Lifesciences, LLC | 2018 | 1 |
| +1 | K180275 | VAMP Optima closed blood sampling system | Edwards Lifesciences, LLC | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 3 | 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.
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? (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 |
|---|---|---|---|
| * | K885281 | Vamp Venous/Arterial Blood Management ProtectionSummary page 4…Sampling System Classification Name Catheter, Continuous Flush (CFR 21 870.1210) Regulation Class II Class/Product Code KRA Predicate Device(s) K885281: VAMP Venous/Arterial Blood Management Protection System The subject Edwards Venous/Arterial Blood Managem… | 1989 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 26, 2021 | Class II | Z-1960-2021 | Under Investigation by firm | There is a potential that the pressure tubing may detach from the blood sampling system |
| May 26, 2021 | Class II | Z-1963-2021 | Under Investigation by firm | There is a potential that the pressure tubing may detach from the blood sampling system |
| May 26, 2021 | Class II | Z-1964-2021 | Under Investigation by firm | There is a potential that the pressure tubing may detach from the blood sampling system |
| May 26, 2021 | Class II | Z-1961-2021 | Under Investigation by firm | There is a potential that the pressure tubing may detach from the blood sampling system |
| May 26, 2021 | Class II | Z-1966-2021 | Under Investigation by firm | There is a potential that the pressure tubing may detach from the blood sampling system |
| May 26, 2021 | Class II | Z-1962-2021 | Under Investigation by firm | There is a potential that the pressure tubing may detach from the blood sampling system |
| May 26, 2021 | Class II | Z-1965-2021 | Under Investigation by firm | There is a potential that the pressure tubing may detach from the blood sampling system |
| May 26, 2021 | Class II | Z-1959-2021 | Under Investigation by firm | There is a potential that the pressure tubing may detach from the blood sampling system |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All KRA devicesKRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
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 | — |
What is it indicated for?
VAMP Adult and VAMP Plus: To be used only for blood withdrawal. The blood sampling system is indicated for use on patients requiring periodic withdrawal of blood samples from arterial and central line catheters, including peripherally inserted central catheters and central venous catheters, which are attached to pressure monitoring lines. VAMP Jr.: To be used only for blood withdrawal. The blood sampling system is indicated for use on pediatric patients…
Read the full statement (101 words)
VAMP Adult and VAMP Plus:
To be used only for blood withdrawal.
The blood sampling system is indicated for use on patients requiring periodic withdrawal of blood samples from arterial and central line catheters, including peripherally inserted central catheters and central venous catheters, which are attached to pressure monitoring lines.
VAMP Jr.:
To be used only for blood withdrawal.
The blood sampling system is indicated for use on pediatric patients (including neonates) requiring periodic withdrawal of blood samples from umbilical, arterial and central line catheters, including peripherally inserted central catheters and central venous catheters, which are attached to pressure monitoring lines.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161962 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161962: VAMP Venous/Arterial Blood Management Protection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161962
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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