510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K951113Substantially Equivalent

Cross-Checks

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

K951113 is the FDA 510(k) clearance record for CROSS-CHECKS, a class II device, cleared for Steritec Products Mfg Co, Inc. on under FDA product code LRT (Indicator, Sterilization). FDA records list 22 510(k) clearances for Steritec Products Mfg Co, Inc., from to . As of , FDA records show no recalls naming K951113.

Clearance record

Decision date
Received
(528 days to decision)
Product code
LRT Indicator, Sterilization
Regulation
21 CFR 880.2800
Device class
Class II
Review panel
General Hospital
Applicant
Steritec Products Mfg Co, Inc. 680 Atchison Way, Suite #600, Castle Rock CO
510(k) summary
Summary
Third party review
No

Clearances, product code LRT

Trailing 12 months

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

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