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510(k) K213809

3M Attest Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam Challenge Pack, 3M Attest Auto-reader, 3M Attest Mini Auto-reader by 3M Company — Product Code FRC

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 6, 2022
Date Received: December 6, 2021
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Indicator, Biological Sterilization Process
Device Class: Class II
Regulation Number: 880.2800
Review Panel: HO
Submission Type

Other clearances by 3M Company

K243501 — 3M Attest Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M (January 28, 2025)
K242538 — 3M Attest Super Rapid Readout Biological Indicator 1493; 3M Attest Super Rap (November 25, 2024)
K241959 — 3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD); 3M Attest Auto-r (October 18, 2024)
K241710 — 3M Attest Super Rapid Readout Biological Indicator 1492V; 3M Attest Auto-rea (September 12, 2024)
K241542 — 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (June 27, 2024)
K240717 — 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hy (June 27, 2024)
DEN230068 — 3M Attest eBowie-Dick Test Card 10135 3M Attest eBowie-Dick Card Holder 1013 (May 21, 2024)
K233814 — 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PC (March 15, 2024)
K222578 — 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) (May 18, 2023)
K222859 — 3M V.A.C. Peel and Place Dressing Kit, Small (EZ10SML), 3M V.A.C. Peel and Place (March 23, 2023)

Other clearances for product code FRC

K252680 — Celerity 20 HP Biological Indicator (September 24, 2025)
K251122 — Terragene® Bionova® BT20 Biological Indicator (August 4, 2025)
K251452 — Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB05 (June 6, 2025)
K250044 — Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB05 (February 6, 2025)
K250061 — Celerity Incubator (February 6, 2025)
K243501 — 3M Attest Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M (January 28, 2025)
K242453 — Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (December 12, 2024)
K242538 — 3M Attest Super Rapid Readout Biological Indicator 1493; 3M Attest Super Rap (November 25, 2024)
K241959 — 3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD); 3M Attest Auto-r (October 18, 2024)
K231383 — Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Biono (September 18, 2024)