510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K894398Substantially Equivalent

Sterigage Integrator Test Pack for Ethylene Oxide

Pymah Corp., No. Hollywood CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894398 is the FDA 510(k) clearance record for STERIGAGE INTEGRATOR TEST PACK FOR ETHYLENE OXIDE, a class II device, cleared for Pymah Corp. on under FDA product code FRC (Indicator, Biological Sterilization Process). FDA records list one 510(k) clearance for Pymah Corp. As of , FDA records show no recalls naming K894398.

Clearance record

Decision date
Received
(56 days to decision)
Product code
FRC Indicator, Biological Sterilization Process
Regulation
21 CFR 880.2800
Device class
Class II
Review panel
General Hospital
Applicant
Pymah Corp. Ati-Division Of Pymah Corp., No. Hollywood CA
Third party review
No

Clearances, product code FRC

Trailing 12 months
1 clearance under product code FRC 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 FRC, 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