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
K111150Substantially Equivalent

Steritec Smart-Read Biological Test Pack with Instant Readout Integrator

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

K111150 is the FDA 510(k) clearance record for STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, a class II device, cleared for Steritec Products Mfg Co, Inc. on under FDA product code FRC (Indicator, Biological Sterilization Process). FDA records list 22 510(k) clearances for Steritec Products Mfg Co, Inc., from to . As of , FDA records show 3 recalls naming K111150.

Clearance record

Decision date
Received
(74 days to decision)
Product code
FRC Indicator, Biological Sterilization Process
Regulation
21 CFR 880.2800
Device class
Class II
Review panel
General Hospital
Applicant
Steritec Products Mfg Co, Inc. 74 Inverness Dr. E., Engelwood CO
510(k) summary
Statement
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