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
K103277Substantially Equivalent

3M Attest 1491 Super Rapid Readout Biological Indicator; 3M Attest 490 Auto-Reader

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

K103277 is the FDA 510(k) clearance record for 3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER, a class II device, cleared for 3M Company-3M Health Care on under FDA product code FRC (Indicator, Biological Sterilization Process). FDA records list 2 510(k) clearances for 3M Company-3M Health Care, from to . As of , FDA records show one recall naming K103277.

Clearance record

Decision date
Received
(165 days to decision)
Product code
FRC Indicator, Biological Sterilization Process
Regulation
21 CFR 880.2800
Device class
Class II
Review panel
General Hospital
Applicant
3M Company-3M Health Care 3m Center, Bldg. 275-5w-06, St. Paul MN
510(k) summary
Summary PDF
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