# K011899: PF 5050 Pressure Unit, Model PF 5050

- Pathway: 510(k) (Traditional)
- Applicant: Perimed AB
- Decided: Nov 6, 2001 after 141 days
- Product code: DPW (Flowmeter, Blood, Cardiovascular)
- Device class: 2
- Regulation: 21 CFR 870.2100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K951486 (1995). 1 ancestor in all.
3 later devices descend from it; 2 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)
- K951486: Model PV2000 Vascular Microlaboratory, Vasamedics, LLC (1995) Summary page 1.

## Most influential descendants
- K152930: PeriFlux6000 (2016), 1 descendant of its own
- K243852: Elfor-L (2025), 0 descendants of its own
- K102433: Moorvms-Pres Pressure Cuff Controller (2010), 0 descendants of its own

## Indications for use
Use of the PF 5050 Pressure Unit is indicated for non-invasive Pulse Volume waveform Recordings (PVR) on extremities of patients with vascular diseases. it is also intended to measure and control the pressure in a biood pressure cuff to simplify simultaneous measurements of perfusion and pressure when used in conjunction with a laser Doppler perfusion monitor.

Source page: https://510kreport.com/device/K011899
Methodology: https://510kreport.com/methodology