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3M Company

St. Paul, MN, US

3M Company appears in FDA device records in St. Paul, MN. FDA records list 146 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
146
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

Showing 50 of 146

FDA records hold 146 510(k) clearances for 3M Company between 1984 and 2025. The busiest year on record is 1991, with 10. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for 3M Company, by decision year
YearClearances
19841
19861
19898
19906
199110
19922
19932
19949
19953
19965
19975
19984
19992
20002
20011
20021
20033
20042
20055
20061
20073
20081
20094
20105
20112
20122
20134
20141
20155
20161
20176
20184
20196
20209
20213
20228
20231
20247
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K2435013M™ 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 490MFRCSubstantially Equivalent
K2425383M™ 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 490MFRCSubstantially Equivalent
K2419593M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD); 3M™ Attest™ Auto-reader (490); 3M™ Attest™ Auto-reader (490H); 3M™ Attest™ Mini Auto-reader (490M)FRCSubstantially Equivalent
K2417103M™ Attest™ Super Rapid Readout Biological Indicator 1492V; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490MFRCSubstantially Equivalent
K2415423M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)FRCSubstantially Equivalent
K2407173M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348EFRCSubstantially Equivalent
DEN2300683M™ Attest™ eBowie-Dick Test Card 10135 3M™ Attest™ eBowie-Dick Card Holder 10135CH 3M™ Attest™ eBowie-Dick Auto-reader 1190SBEUnknown
K2338143M™ 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)FRCSubstantially Equivalent
K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)KKXSubstantially Equivalent
K2225083M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248JOJSubstantially Equivalent
K2221523M™ Attest™ Hydrogen Peroxide Indicator Tape 1228JOJSubstantially Equivalent
K2117053M Attest Rapid Readout Biological Indicator, 1295FRCSubstantially Equivalent
K2209423M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES)JOJSubstantially Equivalent
K2205643M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam Indicator Tape 1355JOJSubstantially Equivalent
K2205073M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, LargePZWSubstantially Equivalent
K2120223M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348EQKMSubstantially Equivalent
K2138093M Attest Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam Challenge Pack, 3M Attest Auto-reader, 3M Attest Mini Auto-readerFRCSubstantially Equivalent
K2120813M(TM) Comply(TM) Hydrogen Peroxide Indicator Tape 1228JOJSubstantially Equivalent
K2106033M Bair Hugger Temperature Management System (Model 675)DWJSubstantially Equivalent
K2102773M Attest Rapid Readout Biological Indicator, 1295FRCSubstantially Equivalent
K2034583M Comply Hydrogen Peroxide Chemical Indicator 1248JOJSubstantially Equivalent
K2009963M Attest Rapid Readout Biological IndicatorFRCSubstantially Equivalent
K2032853M Comply Hydrogen Peroxide Indicator Tape 1228JOJSubstantially Equivalent
K2032843M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical IndicatorQKMSubstantially Equivalent
K200299Curos Jet Disinfecting CapQBPSubstantially Equivalent
K2008353M Tegaderm CHG Chlorhexidine Gluconate Gel PadFROSubstantially Equivalent
K2007663M Attest Steam Chemical Integrator Test PackFRCSubstantially Equivalent
K1925503MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 and 490HFRCSubstantially Equivalent
K2000923MTM AttestTM Mini Auto-reader 490MFRCSubstantially Equivalent
K1932543M Attest Steam Chemical IntegratorJOJSubstantially Equivalent
K1912363M™ Attest™ Steam Chemical IntegratorsJOJSubstantially Equivalent
K1929373M Comply Hydrogen Peroxide Chemical IndicatorJOJSubstantially Equivalent
K1926733M™ Comply™ Hydrogen Peroxide Indicator Tape 1228JOJSubstantially Equivalent
K1832113M Comply Hydrogen Peroxide Chemical IndicatorJOJSubstantially Equivalent
K1832093M Comply Hydrogen Peroxide Indicator TapeJOJSubstantially Equivalent
K1735193M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5 Steam-Plus Chaallenge Pack, 3M Attest Auto-reader, 3M Attest Auto-readerFRCSubstantially Equivalent
K1734373M Attest Super Rapid Readout Biological Indicator 1492V, 3M Attest Auto-reader 490, 3M Attest Auto-reader 490HFRCSubstantially Equivalent
K1734353M Attest Rapid Readout Biological IndicatorFRCSubstantially Equivalent
K1735843M Attest Super Rapid Readout Biological Indicator, 3M Attest Auto-reader, 3M Attest Auto-readerFRCSubstantially Equivalent
K1713733M Bair Hugger Model 675 Total Temperature Management SystemDWJSubstantially Equivalent
K1703213M Comply Hydrogen Peroxide Chemical Indicator 1248JOJSubstantially Equivalent
K1705633M Comply Hydrogen Peroxide Indicator TapeJOJSubstantially Equivalent
K1710033M Attest Rapid Readout Biological Indicator, 3M Attest Auto-readerFRCSubstantially Equivalent
K1719083M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement DressingSELSubstantially Equivalent
K1534103M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement DressingSELSubstantially Equivalent
K1605463M Attest Rapid Readout Biological IndicatorFRCSubstantially Equivalent
K1520603M Attest Rapid Readout Biological Indicator 1295FRCSubstantially Equivalent
K1506943M Comply Hydrogen Peroxide Indicator Tape 1228JOJSubstantially Equivalent
K1506223M Comply Hydrogen Peroxide Chemical Indicator 1248JOJSubstantially Equivalent
K1504773M Comply Indicator Tape for Ethylene Oxide (EO) SterilizationJOJSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

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Data as of , FDA export datePage updated Source: openFDA, public domain