Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tsi, 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) |
|---|---|---|---|---|---|
| K896515 | LASERFLO BLOOD PERFUSION MONITOR, MODEL BPM2 | Tsi, Inc. | 1990-02-13 | 90 | 0 |
| K875179 | MODIFIED LASERFLO BLOOD PERFUSION MONITOR, BPM403A | Tsi, Inc. | 1988-09-19 | 277 | 0 |
| K864259 | MODIFIED LASERFLO BLOOD PERFUSION MONITOR | Tsi, Inc. | 1987-02-20 | 114 | 0 |
| K851057 | LASERFLO BLOOD PERFUSION MONITOR 403 | Tsi, Inc. | 1985-06-24 | 102 | 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