Seabrook Medical Systems, Inc.: FDA clearances and approvals
Seabrook Medical Systems, Inc. has 12 FDA 510(k) clearances (first 1984, latest 1995), across 3 product codes in 2 review panels. Median 510(k) review time: 104 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 |
|---|---|---|---|
| ILO | Pack, Hot Or Cold, Water Circulating | 6 | 6 |
| DWJ | System, Thermal Regulating | 5 | 5 |
| DWC | Controller, Temperature, Cardiopulmonary Bypass | 1 | 1 |
Review panels
- Cardiovascular (6)
- Physical Medicine (6)
Most recent Seabrook Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K952086 | TROPICAIR CONVECTIVE WARMING BLANKETS | DWJ | 1995-09-06 | 126 |
| K946196 | TROPICAIR CONVECTIVE WARING SYSTEM | DWJ | 1995-09-06 | 260 |
| K931203 | COOL-AID | ILO | 1994-02-22 | 350 |
| K923104 | TROPIC-AIR | DWJ | 1993-07-13 | 383 |
| K914182 | GOLDEN THERMAL(R) | ILO | 1991-10-18 | 30 |
| K902756 | TROPI-COOL | DWJ | 1990-10-22 | 122 |
| K902269 | ELECTRI-COOL(TM) LIQUID-CIRCULAT. THERMAL THERAPY | ILO | 1990-06-21 | 31 |
| K902268 | PEDIA-TEMP(TM) LIQUID-CIRCULATING HYPO-HYPERTHERM. | ILO | 1990-06-21 | 31 |
| K882310 | DUAL-TEMP(TM) COOLING/WARMING UNIT | ILO | 1988-09-23 | 112 |
| K881322 | MINI-TEMP(TM) | DWJ | 1988-06-22 | 86 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Seabrook Medical Systems, Inc..
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 Seabrook Medical Systems, Inc. have?
Seabrook Medical Systems, Inc. has 12 FDA 510(k) clearances (first 1984, latest 1995), across 3 product codes in 2 review panels.
How long does FDA take to clear Seabrook Medical Systems, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Seabrook Medical Systems, Inc.'s cleared 510(k)s is 104 days.
What devices does Seabrook Medical Systems, Inc. make?
Its most frequent FDA product codes are ILO (Pack, Hot Or Cold, Water Circulating, 6); DWJ (System, Thermal Regulating, 5); DWC (Controller, Temperature, Cardiopulmonary Bypass, 1).
Has Seabrook Medical Systems, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Seabrook Medical Systems, Inc. Related entities may recall under other names.
Next steps
- See all 12 Seabrook Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ILO, Seabrook Medical Systems, Inc.'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.