Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Invivo Research Labs, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
84 daysmedian FDA review time
153 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K864730 | INVIVO PULSE OXIMETER, MODEL 4500 | Invivo Research Labs, Inc. | 1987-05-06 | 153 | 0 |
| K864889 | OMNI-TRAK | Invivo Research Labs, Inc. | 1987-03-06 | 84 | 0 |
| K833978 | OMEGA 5000 | Invivo Research Labs, Inc. | 1984-03-09 | 113 | 0 |
| K810838 | NEONATAL BLOOD PRESSURE CUFF | Invivo Research Labs, Inc. | 1981-04-03 | 7 | 0 |
| K800066 | NIASTAT | Invivo Research Labs, Inc. | 1980-02-29 | 49 | 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