# K982986: Tubing Blood Flow Meter Model Number HD-800

- Pathway: 510(k) (Traditional)
- Applicant: Koven Technology, Inc.
- Decided: Nov 24, 1998 after 90 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 K872048 (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)
- K872048: Transonic Flowmeter, Transonic Systems, Inc. (1988) Summary page 1.

## Indications for use
The Model HD-800 Tubing Blood Flow Meter is indicated for the measurement of volume blood flow through extracorporeal tubing during the performance of hemodialysis and cardiopulmonary bypass procedures.

Source page: https://510kreport.com/device/K982986
Methodology: https://510kreport.com/methodology