510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001649Substantially Equivalent

Steritec Autoclave Tapes, Model Ci122 & Ci1234

Steritec Products, Inc., Castle Rock CO / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)

K001649 is the FDA 510(k) clearance record for STERITEC AUTOCLAVE TAPES, MODEL CI122 & CI1234, a class II device, cleared for Steritec Products, Inc. on under FDA product code JOJ (Indicator, Physical/Chemical Sterilization Process). FDA records list 13 510(k) clearances for Steritec Products, Inc., from to . As of , FDA records show no recalls naming K001649.

Clearance record

Decision date
Received
(24 days to decision)
Product code
JOJ Indicator, Physical/Chemical Sterilization Process
Regulation
21 CFR 880.2800
Device class
Class II
Review panel
General Hospital
Applicant
Steritec Products, Inc. 599 Topeka Way, Suite 700, Castle Rock CO
510(k) summary
Statement
Third party review
No

Clearances, product code JOJ

Trailing 12 months
3 clearances under product code JOJ in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JOJ, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260