510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K933619Substantially Equivalent

Pd-Pak

General Medical Mfg. Co., Richmond VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K933619 is the FDA 510(k) clearance record for PD-PAK, a class II device, cleared for General Medical Mfg. Co. on under FDA product code MLW (Warmer, Peritoneal Dialysate). FDA records list one 510(k) clearance for General Medical Mfg. Co. As of , FDA records show no recalls naming K933619.

Clearance record

Decision date
Received
(218 days to decision)
Product code
MLW Warmer, Peritoneal Dialysate
Regulation
21 CFR 876.5630
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
General Medical Mfg. Co. 8741 Landmark Rd., Richmond VA
510(k) summary
Statement
Third party review
No

Clearances, product code MLW

Trailing 12 months

FDA records hold no clearances under product code MLW in the trailing twelve months.

FDA records show no clearances under product code MLW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MLW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260