510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K771070Substantially Equivalent

Dry Heat Sterilizer

Cpac, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K771070 is the FDA 510(k) clearance record for DRY HEAT STERILIZER, a class II device, cleared for Cpac, Inc. on under FDA product code KMH (Sterilizer, Dry Heat). FDA records list one 510(k) clearance for Cpac, Inc. As of , FDA records show no recalls naming K771070.

Clearance record

Decision date
Received
(30 days to decision)
Product code
KMH Sterilizer, Dry Heat
Regulation
21 CFR 880.6870
Device class
Class II
Review panel
General Hospital
Applicant
Cpac, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code KMH

Trailing 12 months

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

FDA records show no clearances under product code KMH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KMH, 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