# K021571: Transonic Flow-QC Set Model ADT1010

- Pathway: 510(k) (Traditional)
- Applicant: Transonic Systems, Inc.
- Decided: Aug 12, 2002 after 90 days
- Product code: MQS (System, Hemodialysis, Access Recirculation Monitoring)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002816 (2000). 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)
- K002816: Transonic Hemodialysis Flow Reverser, Model B Flowrev, Transonic Systems, Inc. (2000)

## Recalls of this device
- Feb 15, 2018 · Class II · Z-1776-2018: The sterility of the device cannot be assured. There is a potential for an increased risk of infection.

## Indications for use
The Transonic Flow-QC Set is indicated for use as part of an extracorporeal blood circuit for hemodialysis when the Transonic HDOl System will be use to make access flow, recirculation, and/or cardiac output measurements during the patient’s hemodialysis treatment.

Source page: https://510kreport.com/device/K021571
Methodology: https://510kreport.com/methodology