# K002186: Vascular Assist

- Pathway: 510(k) (Traditional)
- Applicant: Huntleigh Healthcare, Inc.
- Decided: May 2, 2001 after 286 days
- Product code: DPW (Flowmeter, Blood, Cardiovascular)
- Device class: 2
- Regulation: 21 CFR 870.2100
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K183574: SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes (2019), 5 descendants of its own
- K121108: Dopplex Ability (2013), 5 descendants of its own
- K200337: FloPatch (FP120) (2020), 4 descendants of its own
- K143152: TM-ABI system (2015), 4 descendants of its own
- K222242: FloPatch FP120 (2022), 3 descendants of its own

## Recalls of this device
- May 6, 2005 · Not classified · Z-0865-05: The acoustic display of Mechanical Index and Thermal Index is inaccurate - two transducers may exceed limits for acoustic intensity and MI.

Source page: https://510kreport.com/device/K002186
Methodology: https://510kreport.com/methodology