510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MLWClass II

Warmer, Peritoneal Dialysate

21 CFR 876.5630 / Gastroenterology, Urology
FDA source (opens on fda.gov)

MLW is the FDA product code for Warmer, Peritoneal Dialysate, a class II device type, regulated under 21 CFR 876.5630. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
MLW
Device name
Warmer, Peritoneal Dialysate
Regulation
21 CFR 876.5630
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
6
Ingested recalls
0

Clearances, product code MLW

By decision year
6 clearances under product code MLW with a decision year between 1994 and 2025, 1994 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code MLW by decision year
YearClearances
19941
19971
19991
20021
20131
20251

Applicants with the most clearances

Product code MLW
Applicants holding the most 510(k) clearances under product code MLW
ApplicantClearances
Thermasolutions LLC.2
General Medical Mfg. Co.1
Hemocleanse, Inc.1
Impact Case Technologies, Inc.1
Stickman Industries, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code