# K022047: Phlebotest 2000

- Pathway: 510(k) (Traditional)
- Applicant: Osborn Medical Corp.
- Decided: Nov 4, 2002 after 133 days
- Product code: JOM (Plethysmograph, Photoelectric, Pneumatic Or Hydraulic)
- Device class: 2
- Regulation: 21 CFR 870.2780
- 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 K882547 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K882547: Varitest, Eureka AB (1988) Summary page 1.

## Indications for use
Phlebotest 2000 is a system for peripheral vascular diagnostic investigations. Outflow phethysmography (OP) Passive Drain and Refill (PDR) Exercise Venous Plethysmography (EVP) Triple Test (TTT) Combination of OP, PDR, and EVP Either Strain Gauges or Air Pressure Cuffs

Source page: https://510kreport.com/device/K022047
Methodology: https://510kreport.com/methodology