510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN230068Unknown

3M™ Attest™ eBowie-Dick Test Card 10135 3M™ Attest™ eBowie-Dick Card Holder 10135CH 3M™ Attest™ eBowie-Dick Auto-reader 1190

3M Company, St. Paul MN / Direct, Unknown
FDA source (opens on fda.gov)

DEN230068 is the FDA 510(k) clearance record for 3M™ Attest™ eBowie-Dick Test Card 10135 3M™ Attest™ eBowie-Dick Card Holder 10135CH 3M™ Attest™ eBowie-Dick Auto-reader 1190, a class II device, cleared for 3M Company on under FDA product code SBE (Digital Physical/Chemical Sterilization Process Sensor). FDA's definition for product code SBE reads: "A digital physical/chemical sterilization process sensor is a device intended to monitor one or more parameter(s) of the sterilization process. The adequacy of the sterilization conditions as measured by the parameter(s) is/are indicated...". FDA records list 146 510(k) clearances for 3M Company, from to . As of , FDA records show no recalls naming DEN230068.

Clearance record

Decision date
Received
(235 days to decision)
Product code
SBE Digital Physical/Chemical Sterilization Process Sensor
Regulation
21 CFR 880.2801
Device class
Class II
Review panel
General Hospital
Applicant
3M Company 3m Center, St. Paul MN
Third party review
No

Clearances, product code SBE

Trailing 12 months

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

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