510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K213262Substantially Equivalent

CELERITY HP Chemical Indicator

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

K213262 is the FDA 510(k) clearance record for CELERITY HP Chemical Indicator, a class II device, cleared for STERIS Corporation on under FDA product code QKM (A Chemical Vapor Sterilization Multivariable Chemical Indicator). FDA's definition for product code QKM reads: "A chemical vapor sterilization multivariable chemical indicator monitors two or more parameters of a chemical vapor sterilization process". FDA records list 227 510(k) clearances for STERIS Corporation, from to . As of , FDA records show no recalls naming K213262.

Clearance record

Decision date
Received
(99 days to decision)
Product code
QKM A Chemical Vapor Sterilization Multivariable Chemical Indicator
Regulation
21 CFR 880.2800
Device class
Class II
Review panel
General Hospital
Applicant
STERIS Corporation 5960 Heisley Rd., Mentor OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QKM

Trailing 12 months

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

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