Medical device manufacturer
3M Company
3M Company holds 334 FDA 510(k) clearances across 112 product codes. Median elapsed review time is 67 days. openFDA lists 2 recall records naming the company. FDA publishes it under 6 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 334
- Product codes
- 112
- Median review
- 67 days
- Recall records
- 2
How does FDA spell 3M Company?
FDA publishes this company under 6 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| 3M | device/510k | normalised |
| 3M COMPANY | device/registrationlisting | normalised |
| 3M Company | device/recall | normalised |
| 3M Company | device/510k | normalised |
| 3M Company | device/enforcement | normalised |
| 3M Company Corp | device/510k | normalised |
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does 3M Company file in?
112 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| FRC | Indicator, Biological Sterilization Process | 32 | 107 days | |
| JOJ | Indicator, Physical/Chemical Sterilization Process | 24 | 84 days | |
| EBF | Material, Tooth Shade, Resin | 18 | 40 days | |
| ESD | Hearing Aid, Air-Conduction, Prescription | 16 | 22 days | |
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 13 | 44 days | |
| EMA | Cement, Dental | 12 | 51 days | |
| FRO | Dressing, Wound, Drug | 10 | 125 days | |
| FRN | Pump, Infusion | 8 | 82 days | |
| DQD | Stethoscope, Electronic | 6 | 28 days | |
| FXX | Mask, Surgical | 6 | 48 days | |
| KGX | Tape And Bandage, Adhesive | 6 | 22 days | |
| ELW | Material, Impression | 5 | 42 days | |
| GXY | Electrode, Cutaneous | 5 | 32 days | |
| KLE | Agent, Tooth Bonding, Resin | 5 | 41 days | |
| KMF | Bandage, Liquid | 5 | 79 days | |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 4 | 79 days | |
| EBG | Crown And Bridge, Temporary, Resin | 4 | 56 days | |
| EBZ | Activator, Ultraviolet, For Polymerization | 4 | 65 days | |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 4 | 36 days | |
| IXW | Processor, Radiographic-Film, Automatic | 4 | 40 days | |
| KKX | Drape, Surgical, Antimicrobial | 4 | 140 days | |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 4 | 46 days | |
| LWM | Device, Electrical Dental Anesthesia | 4 | 96 days | |
| DRX | Electrode, Electrocardiograph | 3 | 50 days | |
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 3 | 58 days |
Showing the 25 they file in most, of 112.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has 3M Company had a recall?
openFDA lists 2 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.
Z-2231-2025Class IIOpen, ClassifiedLGZ
Notice was issued to clarify flow rates related to the inlet fluid temperature.
Z-2483-2025Class IOpen, ClassifiedBSB
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.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has 3M Company cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| 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 | 77 | |
| 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 | 91 | |
| 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 | 107 | |
| 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 | 90 | |
| K241542 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD) | FRC | 27 | |
| K240717 | 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | FRC | 104 | |
| 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 | 106 | |
| K222578 | 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) | KKX | 266 | |
| 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 | 182 | |
| K223263 | Prevena Plus 125 Therapy Unit | QFC | 112 |
Source: openFDA device/510k · retrieved
Where is 3M Company registered?
FDA lists 5 registered establishments for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what 3M Company files next
Get an email when this company clears a new device, or when anything is recalled in a product code you follow.
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.