# K990039: Gambro DQM 200

- Pathway: 510(k) (Traditional)
- Applicant: Gambro Healthcare
- Decided: Jan 27, 2000 after 386 days
- Product code: LFP (Conductivity Rate, Urea Nitrogen)
- Device class: 2
- Regulation: 21 CFR 862.1770
- 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 K925581 (1995). 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)
- K925581: Baxter Biostat 1000 Urea Monitor, Baxter Healthcare Corp (1995) Summary page 1.

## Indications for use
The Gambro Dialysis Quality Monitor DQM 200 is to act as a clinical tool aiding the physician to establish a dialysis dose of treatment of the patient. The DQM 200 performs a continuous measurement of the spent dialysate flow from a dialysis machine. From this measured data together with patient and treatment data provided by the operator, the DQM 200 derives clinical parameters helpful to the physician in evaluating the dialysis dose.

Source page: https://510kreport.com/device/K990039
Methodology: https://510kreport.com/methodology