3M Company: FDA clearances and approvals
3M Company has 330 FDA 510(k) clearances (first 1976, latest 2025), plus 1 PMA and 2 De Novo decisions, across 115 product codes in 16 review panels. Median 510(k) review time: 65 days. Since 2017 its median was 90 days, against 129 days for all cleared 510(k)s in the same product codes. openFDA lists 2 product recalls by a recalling firm named 3M Company.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 5 | 80 |
| 2013 | 4 | 204 |
| 2014 | 1 | 180 |
| 2015 | 6 | 147 |
| 2016 | 2 | 58 |
| 2017 | 7 | 150 |
| 2018 | 5 | 98 |
| 2019 | 7 | 32 |
| 2020 | 9 | 99 |
| 2021 | 4 | 44 |
| 2022 | 8 | 88 |
| 2023 | 1 | 266 |
| 2024 | 6 | 98 |
| 2025 | 1 | 77 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 3M Company's cleared 510(k)s took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 129 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FRC | Indicator, Biological Sterilization Process | 31 | 31 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | 24 | 24 |
| EBF | Material, Tooth Shade, Resin | 18 | 18 |
| ESD | Hearing Aid, Air-Conduction, Prescription | 16 | 16 |
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 13 | 13 |
| EMA | Cement, Dental | 12 | 12 |
| FRO | Dressing, Wound, Drug | 10 | 10 |
| FRN | Pump, Infusion | 8 | 8 |
| DQD | Stethoscope, Electronic | 6 | 6 |
| FXX | Mask, Surgical | 6 | 6 |
Plus 105 more product codes.
Review panels
- General Hospital (96)
- Dental (70)
- General and Plastic Surgery (41)
- Cardiovascular (32)
- Orthopedic (26)
- Ear, Nose and Throat (16)
- Immunology (15)
- Radiology (9)
- Neurology (7)
- Anesthesiology (6)
- Microbiology (4)
- Physical Medicine (4)
- Clinical Chemistry (2)
- Obstetrics and Gynecology (1)
- Ophthalmic (1)
- Clinical Toxicology (1)
Most recent 3M Company 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review 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 | 2025-01-28 | 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 | 2024-11-25 | 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 | 2024-10-18 | 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 | 2024-09-12 | 90 |
| K241542 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD) | FRC | 2024-06-27 | 27 |
| K240717 | 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | FRC | 2024-06-27 | 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 | 2024-03-15 | 106 |
| K222578 | 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) | KKX | 2023-05-18 | 266 |
| K222508 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248 | JOJ | 2022-11-01 | 75 |
| K222152 | 3M Attest Hydrogen Peroxide Indicator Tape 1228 | JOJ | 2022-09-23 | 65 |
320 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN230068 | De Novo | Digital Physical/Chemical Sterilization Process Sensor | 2024-05-21 |
| DEN060009 | De Novo | Respirator, N95, For Use By The General Public In Public Health Medical Emergencies | 2007-05-08 |
| P850069 | PMA | KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE | 1987-05-07 |
Recalls
2 product recalls in 2 recall events; 2 initiated in the last five years. Most recent: 2025-04-22.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of 3M Company's product codes (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Frequently asked questions
How many FDA 510(k) clearances does 3M Company have?
3M Company has 330 FDA 510(k) clearances (first 1976, latest 2025), plus 1 PMA and 2 De Novo decisions, across 115 product codes in 16 review panels.
How long does FDA take to clear 3M Company's 510(k)s?
The median time from FDA receipt to decision across 3M Company's cleared 510(k)s is 65 days. Since 2017: 90 days, versus 129 days for all cleared 510(k)s in the same product codes.
What devices does 3M Company make?
Its most frequent FDA product codes are FRC (Indicator, Biological Sterilization Process, 31); JOJ (Indicator, Physical/Chemical Sterilization Process, 24); EBF (Material, Tooth Shade, Resin, 18).
Has 3M Company had device recalls?
openFDA lists 2 product recalls in 2 recall events by a recalling firm whose name matches 3M Company; the most recent began 2025-04-22. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 330 3M Company clearances with predicates and recalls
- Run predicate analysis for product code FRC, 3M Company's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.