510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163587Substantially Equivalent

VERIFY Incubator for Assert Self Contained Biological Indicators

STERIS Corporation, Mentor OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163587 is the FDA 510(k) clearance record for VERIFY Incubator for Assert Self Contained Biological Indicators, a class II device, cleared for STERIS Corporation on under FDA product code OWP (Biological Sterilization Process Indicator With Recombinant-Dna Plasmid). FDA's definition for product code OWP reads: "A Recombinant-DNA plasmid biological indicator is intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization". FDA records list 227 510(k) clearances for STERIS Corporation, from to . As of , FDA records show no recalls naming K163587.

Clearance record

Decision date
Received
(94 days to decision)
Product code
OWP Biological Sterilization Process Indicator With Recombinant-Dna Plasmid
Regulation
21 CFR 880.2805
Device class
Class II
Review panel
General Hospital
Applicant
STERIS Corporation 5976 Heisley Rd., Mentor OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OWP

Trailing 12 months

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

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