Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lifescience Plus, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253017 | BloodSTOP iX Trauma Matrix (TM-iX-20) | Lifescience Plus, Inc. | 2026-04-30 | 223 | 0 |
| K160130 | BloodSTOP iX Battle Matrix | Lifescience Plus, Inc. | 2016-06-29 | 161 | 0 |
| K072681 | BLOODSTOP HEMOSTATIC GAUZE; IX HEMOSTATIC GAUZE | Lifescience Plus, Inc. | 2007-11-02 | 42 | 0 |
| K071578 | BLOODSTOP AND BLOODSTOP IX HEMOSTATIC GAUZE, MODELS BS-10,BS | Lifescience Plus, Inc. | 2007-09-27 | 111 | 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