510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K915170Substantially Equivalent

Pymah Cold Sterilog Glutaraldehyde Monitor

Pymah Corp., Somerville NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915170 is the FDA 510(k) clearance record for PYMAH COLD STERILOG GLUTARALDEHYDE MONITOR, a class II device, cleared for Pymah Corp. on under FDA product code MED (Sterilant, Medical Devices). FDA records list 11 510(k) clearances for Pymah Corp., from to . As of , FDA records show no recalls naming K915170.

Clearance record

Decision date
Received
(256 days to decision)
Product code
MED Sterilant, Medical Devices
Regulation
21 CFR 880.6885
Device class
Class II
Review panel
General Hospital
Applicant
Pymah Corp. 89 Rte. 206, Somerville NJ
510(k) summary
Statement
Third party review
No

Clearances, product code MED

Trailing 12 months
1 clearance under product code MED in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MED, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260