3M Health Care, Sarns: FDA filings under this applicant name
FDA lists 76 510(k) clearances under the applicant name “3M Health Care, Sarns” (first 1976, latest 1996), across 27 product codes in 4 review panels. Median 510(k) review time under this name: 70 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Terumo, based on public ownership records.
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 |
|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 21 | 21 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 9 | 9 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 6 | 6 |
| DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 5 | 5 |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 4 | 4 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 3 | 3 |
| DWB | Pump, Blood, Cardiopulmonary Bypass, Roller Type | 3 | 3 |
| DTP | Defoamer, Cardiopulmonary Bypass | 2 | 2 |
| DTW | Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass | 2 | 2 |
| DWC | Controller, Temperature, Cardiopulmonary Bypass | 2 | 2 |
Plus 17 more product codes.
Review panels
Most recent 3M Health Care, Sarns 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K960916 | SAMS 8000 CARDIOPLEGIA MONITOR | DSJ | 1996-06-04 | 90 |
| K953901 | SARNS 800 ROLLER PUMP | DWB | 1996-04-19 | 245 |
| K950739 | 3M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEM | DWA | 1995-11-17 | 273 |
| K941653 | SARNS TURBO MEMBRANE OXYGENATOR MODIFICATION | DTZ | 1994-08-24 | 141 |
| K941654 | SARNS FILTERED VENOUS RESERVIOR MODIFICATION | DTP | 1994-07-26 | 112 |
| K940651 | SARNS ULTRASONIC AIR SENSOR | KRL | 1994-05-24 | 98 |
| K935391 | SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PACK | GFA | 1994-02-24 | 108 |
| K934127 | SARNS LOW JETTING AORTIC ARCH CANNULA | DWF | 1994-02-22 | 181 |
| K935977 | SARNS AIR DETECTION SYSTEM | KRL | 1994-02-04 | 53 |
| K915547 | SARNS 8000 DELPHIN II CENTRI PUMP MOD W/INTEGR BAT | KFM | 1993-09-09 | 638 |
66 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named 3M Health Care, Sarns.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under 3M Health Care, Sarns?
FDA lists 76 510(k) clearances under the applicant name “3M Health Care, Sarns” (first 1976, latest 1996), across 27 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by 3M Health Care, Sarns?
The median time from FDA receipt to decision across 510(k)s cleared under the name 3M Health Care, Sarns is 70 days.
Which FDA product codes appear under 3M Health Care, Sarns?
The most frequent FDA product codes under this applicant name are DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 21); DTZ (Oxygenator, Cardiopulmonary Bypass, 9); DTR (Heat-Exchanger, Cardiopulmonary Bypass, 6).
Next steps
- See all 76 3M Health Care, Sarns clearances with predicates and recalls
- Run predicate analysis for product code DWF, 3M Health Care, Sarns's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.