510(k) · Cleared
ClearedVAMP 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 Apr 5, 2018 as substantially equivalent to K161962 (Edwards Lifesciences, LLC, 2016) and 1 other predicate after a 136-day review. Its family tree reaches back 4 generations to 1993. 1 later device descends from it.
- Decided
- Apr 5, 2018
- Review
- 136 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K925638 (1993). 6 ancestors in all, the oldest K885281 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK925638 Phoenix Disposable Pressure Transducer #73-600Baxter Healthcare Corp · 1993 · Recalled
- 3 generations backK141495 Truwave Disposable Pressure TransducerEdwards Lifesciences, LLC · 2014
- 2 generations backK142749 TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC · 2015 · Recalled
- 1 generation backK171996 TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC · 2017 · Recalled
- This deviceK173586 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
Most influential descendants
Showing 1 of 1 · See all- K181684VAMP Plus Venous/Arterial Blood Management Protection 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 |
|---|---|---|---|---|---|
| −4 | K925638 | Phoenix Disposable Pressure Transducer #73-600 | Baxter Healthcare Corp | 1993 | 1 |
| −3 | K141495 | Truwave Disposable Pressure Transducer | Edwards Lifesciences, LLC | 2014 | — |
| −2 | K142749 | TruWave Disposable Pressure Transducer | Edwards Lifesciences, LLC | 2015 | 11 |
| −1 | K171996 | TruWave Disposable Pressure Transducer | Edwards Lifesciences, LLC | 2017 | 1 |
| 0 (this device) | 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 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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.
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 14.5 · 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? (2)
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 |
|---|---|---|---|
| * | K161962 | VAMP Venous/Arterial Blood Management Protection SystemSummary page 4…cation Catheter, Continuous Flush (21 CFR 870.1210) Name Regulation Class II Class/Product Code KRA Primary Predicate K161962: VAMP Venous/Arterial Blood Management Protection System Device (Cleared on November 28, 2016) Secondary… | 2016 |
| * | K171996 | TruWave Disposable Pressure TransducerSummary page 4…KRA Primary Predicate K161962: VAMP Venous/Arterial Blood Management Protection System Device (Cleared on November 28, 2016) Secondary K171996: TruWave™ Disposable Pressure Transducer and associated kits Predicate Device (Cleared on October 23, 2017)… | 2017 |
| † | K060231 | Closed Swabable Stopcock and Minimal Residual Volume Luer-Activated Swabable-Stopcock | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181684 | VAMP Plus Venous/Arterial Blood Management Protection System | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- 5 of the 6 ancestors have a recall of any class.
- Of its descendants, K181684 (Edwards Lifesciences, LLC, 2018) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K161962.
How does its category compare?
All KRA devicesKRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K173586 · printed Nov 5, 2026
Cite this page
510(k) Report. “K173586: VAMP Venous/Arterial Blood Management Protection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K173586
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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