Adroit Medical Systems, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Adroit Medical Systems, Inc.” (first 1992, latest 2008), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 179 days. 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 | 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 |
|---|---|---|---|
| DWJ | System, Thermal Regulating | 2 | 2 |
| ILO | Pack, Hot Or Cold, Water Circulating | 2 | 2 |
| FMW | Cover, Mattress (Medical Purposes) | 1 | 1 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 1 | 1 |
Review panels
- Cardiovascular (2)
- General Hospital (2)
- Physical Medicine (2)
Most recent Adroit Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K073712 | SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100 | DWJ | 2008-06-06 | 158 |
| K973981 | SAFEPASS STERILIZATION POUCH | KCT | 1998-01-29 | 101 |
| K970197 | HTP-1500 LOCALIZED HEAT THERAPY PUMP | ILO | 1997-09-10 | 232 |
| K962983 | STERILE SOFT-TEMP | ILO | 1997-01-10 | 162 |
| K921920 | SOFT-TEMP | DWJ | 1992-12-11 | 232 |
| K921928 | SOFT-COVER | FMW | 1992-11-06 | 196 |
Recalls
openFDA lists no recalls under a recalling firm named Adroit Medical Systems, Inc..
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 Adroit Medical Systems, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Adroit Medical Systems, Inc.” (first 1992, latest 2008), across 4 product codes in 3 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 Adroit Medical Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Adroit Medical Systems, Inc. is 179 days.
Which FDA product codes appear under Adroit Medical Systems, Inc.?
The most frequent FDA product codes under this applicant name are DWJ (System, Thermal Regulating, 2); ILO (Pack, Hot Or Cold, Water Circulating, 2); FMW (Cover, Mattress (Medical Purposes), 1).
Next steps
- See all 6 Adroit Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DWJ, Adroit Medical Systems, 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.