# K903625: Doppler Needle and Flow Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Peripheral Systems Group
- Decided: Nov 7, 1990 after 89 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 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
- K963989: P.D. Access (Percutaneous Doppler) Vascular Access Device (1997), 2 descendants of its own
- K973713: 22 Gauge P.D. Access Vascular Access Device (Catheter/Needle Assembly), 24 Gauge P.D. Access Vascular Access Device (Car (1998), 1 descendant of its own
- K090743: Yield Mini Doppler System (2009), 0 descendants of its own

## Recalls of this device
- May 5, 2010 · Not classified · Z-0132-2011: The packaging of the vascular access device may potentially become damaged, compromising the sterility of the product. Use of a non-sterile product increases risk of patient infection. This recall inv

Source page: https://510kreport.com/device/K903625
Methodology: https://510kreport.com/methodology