3M Attest Super Rapid 5 Steam-Plus Challenge Pack— 510(k) K193154
Substantially Equivalent3M Company
FDA 510(k) clearance K193154 for 3M Attest Super Rapid 5 Steam-Plus Challenge Pack, Substantially Equivalent on 2020-02-07. Applicant: 3M Company. Device class: 2.
Clearance details
- Applicant
- 3M Company
- Product code
- Code FRC
- Device class
- Class 2
- Regulation
- 21 CFR 880.2800
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Paul, MS, US
Recent devices under product code FRC
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- K241710 — 3M Attest Super Rapid Readout Biological Indicator 1492V +3 more
- K240717 — 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
Recalls naming K193154
K-number listed on FDA's recall record- Z-2639-2023 — 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482V; designed to qualify and monitor dynamic-air removal steam sterilization processes
- Z-2640-2023 — 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482VF; designed to qualify and monitor dynamic-air removal steam sterilization processes
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K193154.
Data sourced from openFDA. This site is unofficial and independent of the FDA.