510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K094026Substantially Equivalent

Steri-Dent, Steri-Sure

Cpac, Inc., Leicester NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K094026 is the FDA 510(k) clearance record for STERI-DENT, STERI-SURE, a class II device, cleared for Cpac, Inc. on under FDA product code KMH (Sterilizer, Dry Heat). FDA records list 2 510(k) clearances for Cpac, Inc., from to . As of , FDA records show no recalls naming K094026.

Clearance record

Decision date
Received
(559 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. 2364 Leicester Rd., Leicester NY
510(k) summary
Summary PDF
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