FDA product code MLW: Warmer, Peritoneal Dialysate
MLW is the FDA product code for warmer, peritoneal dialysate. It is a Class II device, regulated under 21 CFR 876.5630 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 6 510(k) submissions under MLW, 1 in the last five years, from 6 different applicants. The average 510(k) review took 210 days (median 193); 445 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Warmer, Peritoneal Dialysate |
| Device class | Class II |
| Regulation | 21 CFR 876.5630 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for MLW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 445 |
Compare with all 510(k) review times · Search every MLW clearance
Top MLW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Thermasolutions, LLC | 1 | 2025-05-05 |
| Thermasolutions, Inc. | 1 | 2013-10-03 |
| Stickman Industries, Inc. | 1 | 2002-09-27 |
| Hemocleanse, Inc. | 1 | 1999-12-30 |
| Impact Case Technologies, Inc. | 1 | 1997-05-19 |
1 more applicants have MLW clearances. See the full list in Caduvo.
Most recent MLW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240447 | Thermasolutions, LLC | ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) | 2025-05-05 | 445 |
| K131583 | Thermasolutions, Inc. | THERMOCHEM HT-2000 | 2013-10-03 | 125 |
| K020542 | Stickman Industries, Inc. | DAYTRIPPER DIALYSATE WARMER | 2002-09-27 | 220 |
| K993330 | Hemocleanse, Inc. | THERMOCHEM-HT SYSTEM | 1999-12-30 | 87 |
| K964825 | Impact Case Technologies, Inc. | FREEDOM TRAVELLER | 1997-05-19 | 168 |
Recalls for MLW devices
openFDA lists no recalls for product code MLW.
Frequently asked questions
What is FDA product code MLW?
MLW is the FDA product code for warmer, peritoneal dialysate. It is a Class II device, regulated under 21 CFR 876.5630 and reviewed by the Gastroenterology and Urology panel.
What device class is MLW?
Class II, regulation 21 CFR 876.5630. Typical premarket route: 510(k).
How long does a 510(k) take for product code MLW?
Across 6 cleared submissions the average was 210 days from receipt to decision (median 193).
Which companies have the most MLW clearances?
Thermasolutions, LLC (1); Thermasolutions, Inc. (1); Stickman Industries, Inc. (1); Hemocleanse, Inc. (1); Impact Case Technologies, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MLW
- Run a recall and safety report across every MLW manufacturer
- Watch product code MLW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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