Chrysalis Intelligence · Sponsors · 3M Company

3M Company

St. Paul, MN, US · 34 510(k) clearances · 2 recalls (1 Class I)

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Total clearances
34
2020-02-07 → 2025-01-28
Last 12 months
0
Product codes
10
Most recent
2025-01-28
Name variants in FDA filings: 3M Company / 3M
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
FRC Indicator, Biological Sterilization Process Class II General Hospital 15 2025-01-28
JOJ — — — 8 2024-05-21
OMP Negative Pressure Wound Therapy Powered Suction Pump Class II General, Plastic Surgery 2 2023-03-23
QKM A Chemical Vapor Sterilization Multivariable Chemical Indicator Class II General Hospital 2 2022-04-20
DWJ System, Thermal Regulating Class II Cardiovascular 2 2021-04-29
KKX — — — 1 2023-05-18
QFC — — — 1 2023-02-13
PZW Catheter Access Cover, Tamper-Resistant Class II General Hospital 1 2022-05-23
QBP — — — 1 2020-10-29
FRO Dressing, Wound, Drug Unclassified Unknown 1 2020-09-04
Safety

Recalls (2)

Class I (serious)
1
Risk of injury / death
Total recalls
2
Currently ongoing
2
Most recent
2025-04-22
DateSeverityStatusRecall # ProductCodeReason
2025-04-22 Class II Ongoing Z-2231-2025 3M Ranger Irrigation Fluid Warming Set, REF 24750 — Notice was issued to clarify flow rates related to the inlet fluid temperature.
2025-04-10 Class I Ongoing Z-2483-2025 3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370 — Field action to clarify the flow rates and inlet fluid temperatures, along with location of the outlet temperature for Ranger Blood/Fluid Warming High Flow Sets…
Filings

All 510(k) clearances (34)

Date K-number Device Code Class Specialty
2025-01-28 K243501 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M FRC Class II General Hospital
2024-11-25 K242538 3M™ Attest™ Super Rapid Readout Biological Indicator 1493; 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M FRC Class II General Hospital
2024-10-18 K241959 3M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD); 3M™ Attest™ Auto-reader (490); 3M™ Attest™ Auto-reader (490H); 3M™ Attest™ Mini Auto-reader (490M) FRC Class II General Hospital
2024-09-12 K241710 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M FRC Class II General Hospital
2024-06-27 K241542 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD) FRC Class II General Hospital
2024-06-27 K240717 3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E FRC Class II General Hospital
2024-05-21 DEN230068 3M™ Attest™ eBowie-Dick Test Card 10135 3M™ Attest™ eBowie-Dick Card Holder 10135CH 3M™ Attest™ eBowie-Dick Auto-reader 1190 JOJ — —
2024-03-15 K233814 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M™ Attest™ Auto-reader (490); 3M™ Attest™ Auto-reader (490H); 3M™ Attest™ Mini Auto-reader (490M) FRC Class II General Hospital
2023-05-18 K222578 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) KKX — —
2023-03-23 K222859 3M V.A.C. Peel and Place Dressing Kit, Small (EZ10SML), 3M V.A.C. Peel and Place Dressing Kit, Medium (EZ10MED), 3M V.A.C. Peel and Place Dressing Kit, Large (EZ10LRG) OMP Class II General, Plastic Surgery
2023-02-13 K223263 Prevena Plus 125 Therapy Unit QFC — —
2022-11-01 K222508 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 JOJ — —
2022-09-23 K222152 3M™ Attest™ Hydrogen Peroxide Indicator Tape 1228 JOJ — —
2022-07-14 K220560 Dermatac Drape OMP Class II General, Plastic Surgery
2022-06-28 K211705 3M Attest Rapid Readout Biological Indicator, 1295 FRC Class II General Hospital
2022-06-24 K220942 3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES) JOJ — —
2022-05-23 K220564 3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam Indicator Tape 1355 JOJ — —
2022-05-23 K220507 3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large PZW Class II General Hospital
2022-04-20 K212022 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E QKM Class II General Hospital
2022-04-06 K213809 3M Attest Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam Challenge Pack, 3M Attest Auto-reader, 3M Attest Mini Auto-reader FRC Class II General Hospital
2021-09-05 K212081 3M(TM) Comply(TM) Hydrogen Peroxide Indicator Tape 1228 JOJ — —
2021-04-29 K210605 3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation DWJ Class II Cardiovascular
2021-03-30 K210603 3M Bair Hugger Temperature Management System (Model 675) DWJ Class II Cardiovascular
2021-03-03 K210277 3M Attest Rapid Readout Biological Indicator, 1295 FRC Class II General Hospital
2020-12-11 K203458 3M Comply Hydrogen Peroxide Chemical Indicator 1248 JOJ — —
2020-12-11 K200996 3M Attest Rapid Readout Biological Indicator FRC Class II General Hospital
2020-12-10 K203285 3M Comply Hydrogen Peroxide Indicator Tape 1228 JOJ — —
2020-12-07 K203284 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator QKM Class II General Hospital
2020-10-29 K200299 Curos Jet Disinfecting Cap QBP — —
2020-09-04 K200835 3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad FRO Unclassified Unknown
2020-07-02 K200766 3M Attest Steam Chemical Integrator Test Pack FRC Class II General Hospital
2020-06-05 K192550 3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 and 490H FRC Class II General Hospital
2020-04-15 K200092 3MTM AttestTM Mini Auto-reader 490M FRC Class II General Hospital
2020-02-07 K193154 3M Attest Super Rapid 5 Steam-Plus Challenge Pack FRC Class II General Hospital
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence