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
K193110Substantially Equivalent

3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E

3M Healthcare, St. Paul MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K193110 is the FDA 510(k) clearance record for 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E, a class II device, cleared for 3M Healthcare 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 21 510(k) clearances for 3M Healthcare, from to . As of , FDA records show one recall naming K193110.

Clearance record

Decision date
Received
(122 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
3M Healthcare 2510 Conway Ave., Bldg. 275-5w-06, St. Paul MN
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