3M Medical Products Group: FDA clearances and approvals
3M Medical Products Group has 12 FDA 510(k) clearances (first 1991, latest 1997), across 8 product codes in 6 review panels. Median 510(k) review time: 89 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LMC | Camera, Multi Format, Radiological | 3 | 3 |
| DRX | Electrode, Electrocardiograph | 2 | 2 |
| GDW | Staple, Implantable | 2 | 2 |
| EMA | Cement, Dental | 1 | 1 |
| ESD | Hearing Aid, Air-Conduction, Prescription | 1 | 1 |
| HRX | Arthroscope | 1 | 1 |
| IXW | Processor, Radiographic-Film, Automatic | 1 | 1 |
| KMF | Bandage, Liquid | 1 | 1 |
Review panels
- Radiology (4)
- General and Plastic Surgery (3)
- Cardiovascular (2)
- Dental (1)
- Ear, Nose and Throat (1)
- Orthopedic (1)
Most recent 3M Medical Products Group 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K971444 | 3M RED DOT 2234 & 2266 RADIOLUCENT MONITORING ELECTRODES | DRX | 1997-06-11 | 51 |
| K955103 | 3M NO STING BARRIER FILM | KMF | 1996-02-05 | 89 |
| K952121 | 3M RESIN CEMENT | EMA | 1995-06-22 | 48 |
| K945726 | 3M(TM) EAR IMPRESSION MATERIAL | ESD | 1995-01-27 | 66 |
| K941718 | 3M FLUID CONTROL SYSTEM 8300 CASSETTE LOAD | HRX | 1994-10-07 | 183 |
| K934333 | 3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE | DRX | 1994-07-07 | 303 |
| K923222 | 3M COLOR LASER IMAGER, MODEL 979 | LMC | 1992-09-30 | 91 |
| K923075 | 3M LASER IMAGER MODEL 969 | LMC | 1992-09-23 | 90 |
| K911252 | PRECISE BARND PI DISPOSABLE SURGICAL STAPLES | GDW | 1991-07-25 | 126 |
| K912225 | 3M DIGITAL RECORDING AUTOMATIC FILM HANDLING UNIT | IXW | 1991-07-22 | 63 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named 3M Medical Products Group.
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.
Frequently asked questions
How many FDA 510(k) clearances does 3M Medical Products Group have?
3M Medical Products Group has 12 FDA 510(k) clearances (first 1991, latest 1997), across 8 product codes in 6 review panels.
How long does FDA take to clear 3M Medical Products Group's 510(k)s?
The median time from FDA receipt to decision across 3M Medical Products Group's cleared 510(k)s is 89 days.
What devices does 3M Medical Products Group make?
Its most frequent FDA product codes are LMC (Camera, Multi Format, Radiological, 3); DRX (Electrode, Electrocardiograph, 2); GDW (Staple, Implantable, 2).
Has 3M Medical Products Group had device recalls?
openFDA lists no recalls under a recalling firm name matching 3M Medical Products Group. Related entities may recall under other names.
Next steps
- See all 12 3M Medical Products Group clearances with predicates and recalls
- Run predicate analysis for product code LMC, 3M Medical Products Group'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.