510(k) · Cleared
ClearedGambro DQM 200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gambro Healthcare · LFP Conductivity Rate, Urea Nitrogen
Cleared on Jan 27, 2000 as substantially equivalent to K925581 (Baxter Healthcare Corp, 1995) after a 386-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Jan 27, 2000
- Review
- 386 days
- Class
- Class II
- Product code
- LFP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K925581 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK925581 Baxter Biostat 1000 Urea MonitorBaxter Healthcare Corp · 1995
- This deviceK990039 Gambro DQM 200Gambro Healthcare · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K925581 | Baxter Biostat 1000 Urea Monitor | Baxter Healthcare Corp | 1995 | — |
| 0 (this device) | K990039 | Gambro DQM 200 | Gambro Healthcare | 2000 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LFP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K925581 | Baxter Biostat 1000 Urea MonitorSummary page 1…ivity in proportion to the urea concentration. Predicate Device: The Gambro DQM 200 is substantially equivalent to the Baxter BioStat 1000 Urea Monitor — 510(k) Number K925581. Examination of the information pertaining to the Baxter BioStat 1000 Urea Monitor demonstrates that this device is substantially… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All LFP devicesLFP Conductivity Rate, Urea Nitrogen: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LFP
FDA has decided no LFP device since 2007.
Median 510(k) review, days · LFP
Too few LFP 510(k)s in any year since 2007 to give a median.
Recalls per year · LFP
No recall names LFP since 2007.
Adverse event reports per year · LFP
No MAUDE report names LFP since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990039 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990039: Gambro DQM 200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990039
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026