# K161962: VAMP Venous/Arterial Blood Management Protection System

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Nov 28, 2016 after 133 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K885281 (1989). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K885281: Vamp Venous/Arterial Blood Management Protection, Baxter Healthcare Corp (1989) Summary page 4.

## Most influential descendants
- K173586: VAMP Venous/Arterial Blood Management Protection System (2018), 1 descendant of its own
- K181684: VAMP Plus Venous/Arterial Blood Management Protection System (2018), 0 descendants of its own
- K180275: VAMP Optima closed blood sampling system (2018), 0 descendants of its own

## Recalls of this device
- May 26, 2021 · Class II · Z-1960-2021: There is a potential that the pressure tubing may detach from the blood sampling system
- May 26, 2021 · Class II · Z-1963-2021: There is a potential that the pressure tubing may detach from the blood sampling system
- May 26, 2021 · Class II · Z-1964-2021: There is a potential that the pressure tubing may detach from the blood sampling system
- May 26, 2021 · Class II · Z-1961-2021: There is a potential that the pressure tubing may detach from the blood sampling system
- May 26, 2021 · Class II · Z-1966-2021: There is a potential that the pressure tubing may detach from the blood sampling system
- May 26, 2021 · Class II · Z-1962-2021: There is a potential that the pressure tubing may detach from the blood sampling system
- May 26, 2021 · Class II · Z-1965-2021: There is a potential that the pressure tubing may detach from the blood sampling system
- May 26, 2021 · Class II · Z-1959-2021: There is a potential that the pressure tubing may detach from the blood sampling system

## Indications for use
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.

Source page: https://510kreport.com/device/K161962
Methodology: https://510kreport.com/methodology