Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Breas Medical AB · Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
239 daysmedian FDA review time
401 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242485 | EveryWare | Breas Medical AB | 2025-05-20 | 272 | 0 |
| K242438 | Clearo | Breas Medical AB | 2025-05-16 | 273 | 0 |
| K233452 | Vivo 45 LS | Breas Medical AB | 2025-01-13 | 451 | 1 |
| K240779 | Vivo 3 | Breas Medical AB | 2024-12-13 | 267 | 0 |
| K240778 | Vivo 1, Vivo 2 | Breas Medical AB | 2024-12-13 | 267 | 0 |
| K193586 | Vivo 45 LS | Breas Medical AB | 2021-01-27 | 401 | 2 |
| K160481 | Vivo 60 | Breas Medical AB | 2016-11-09 | 261 | 0 |
| K090113 | BREAS VIVO 40 SYSTEM | Breas Medical AB | 2009-05-14 | 113 | 0 |
| K071702 | BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 40 | Breas Medical AB | 2008-02-15 | 239 | 0 |
| K063476 | BREAS ISLEEP 20I | Breas Medical AB | 2007-01-22 | 67 | 0 |
| K060657 | ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20. | Breas Medical AB | 2006-08-18 | 158 | 0 |
| K061057 | BREAS ISLEEP 20+ | Breas Medical AB | 2006-06-23 | 67 | 0 |
| K060546 | BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 30 | Breas Medical AB | 2006-05-26 | 86 | 0 |
| K060790 | BREAS, MODEL HA01 | Breas Medical AB | 2006-05-25 | 63 | 0 |
| K053607 | BREAS VIVO 40 SYSTEM | Breas Medical AB | 2006-03-16 | 79 | 0 |
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