Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Seabrook Medical Systems, Inc. · Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
112 daysmedian FDA review time
350 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K946196 | TROPICAIR CONVECTIVE WARING SYSTEM | Seabrook Medical Systems, Inc. | 1995-09-06 | 260 | 0 |
| K952086 | TROPICAIR CONVECTIVE WARMING BLANKETS | Seabrook Medical Systems, Inc. | 1995-09-06 | 126 | 0 |
| K931203 | COOL-AID | Seabrook Medical Systems, Inc. | 1994-02-22 | 350 | 0 |
| K923104 | TROPIC-AIR | Seabrook Medical Systems, Inc. | 1993-07-13 | 383 | 0 |
| K914182 | GOLDEN THERMAL(R) | Seabrook Medical Systems, Inc. | 1991-10-18 | 30 | 0 |
| K902756 | TROPI-COOL | Seabrook Medical Systems, Inc. | 1990-10-22 | 122 | 0 |
| K902268 | PEDIA-TEMP(TM) LIQUID-CIRCULATING HYPO-HYPERTHERM. | Seabrook Medical Systems, Inc. | 1990-06-21 | 31 | 0 |
| K902269 | ELECTRI-COOL(TM) LIQUID-CIRCULAT. THERMAL THERAPY | Seabrook Medical Systems, Inc. | 1990-06-21 | 31 | 1 |
| K882310 | DUAL-TEMP(TM) COOLING/WARMING UNIT | Seabrook Medical Systems, Inc. | 1988-09-23 | 112 | 0 |
| K881322 | MINI-TEMP(TM) | Seabrook Medical Systems, Inc. | 1988-06-22 | 86 | 0 |
| K873699 | ECMO-TEMP (TM) BLOOD WARMING DEVICE | Seabrook Medical Systems, Inc. | 1987-12-22 | 97 | 0 |
| K843146 | MICRO-TEMP PUMPS & MICRO-TEMP PADS | Seabrook Medical Systems, Inc. | 1984-08-17 | 7 | 2 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda