Remington Medical, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Remington Medical, Inc.” (first 1993, latest 2025), across 12 product codes in 7 review panels. Median 510(k) review time under this name: 97 days. Since 2017 the median was 97 days, against 111 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 97 |
| 2014 | 0 | — |
| 2015 | 1 | 120 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 58 |
| 2020 | 0 | — |
| 2021 | 1 | 97 |
| 2022 | 1 | 248 |
| 2023 | 0 | — |
| 2024 | 1 | 88 |
| 2025 | 1 | 153 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Remington Medical, Inc. took a median 97 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 111 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DPW | Flowmeter, Blood, Cardiovascular | 4 | 4 |
| KNW | Instrument, Biopsy | 4 | 4 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 2 | 2 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 1 | 1 |
| DTA | Tester, Pacemaker Electrode Function | 1 | 1 |
| DTE | Pulse-Generator, Pacemaker, External | 1 | 1 |
| DYB | Introducer, Catheter | 1 | 1 |
| EXF | Bag, Bile Collecting | 1 | 1 |
| IZH | System, X-Ray, Mammographic | 1 | 1 |
| KHR | Absorber, Saliva, Paper | 1 | 1 |
Plus 2 more product codes.
Review panels
- Cardiovascular (9)
- General and Plastic Surgery (4)
- General Hospital (2)
- Anesthesiology (1)
- Dental (1)
- Gastroenterology and Urology (1)
- Radiology (1)
Most recent Remington Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251904 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01) | DPW | 2025-11-20 | 153 |
| K241583 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01) | DPW | 2024-08-30 | 88 |
| K211589 | VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger | DPW | 2022-01-27 | 248 |
| K212065 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger | DPW | 2021-10-07 | 97 |
| K191315 | Remington Medical, Inc. Automatic Cutting Needle (NAC) | KNW | 2019-07-12 | 58 |
| K150266 | Remington Medical Inc. Tuohy Epidural Needles | BSP | 2015-06-04 | 120 |
| K130282 | REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT | KNW | 2013-05-13 | 97 |
| K050884 | ADAPTER CABLE | DTA | 2005-05-19 | 42 |
| K040266 | CORE NEEDLE BIOPSY | KNW | 2004-07-09 | 155 |
| K990428 | DRAINAGE BAG | EXF | 1999-08-12 | 182 |
9 earlier clearances. See the full list in Caduvo.
Recalls
20 product recalls in 14 recall events; 2 initiated in the last five years. Most recent: 2023-11-03.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Remington Products Company, LLC (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Remington Medical, Inc.?
FDA lists 19 510(k) clearances under the applicant name “Remington Medical, Inc.” (first 1993, latest 2025), across 12 product codes in 7 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 Remington Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Remington Medical, Inc. is 97 days. Since 2017: 97 days, versus 111 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Remington Medical, Inc.?
The most frequent FDA product codes under this applicant name are DPW (Flowmeter, Blood, Cardiovascular, 4); KNW (Instrument, Biopsy, 4); DSA (Cable, Transducer And Electrode, Patient, (Including Connector), 2).
Next steps
- See all 19 Remington Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DPW, Remington Medical, Inc.'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.