Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Invuity, 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) |
|---|---|---|---|---|---|
| K191583 | PhotonBlade with Smoke Evacuation | Invuity, Inc. | 2020-03-06 | 266 | 0 |
| K162053 | PhotonBlade | Invuity, Inc. | 2016-09-15 | 52 | 0 |
| K113697 | EIGR SURGICAL ILLUMINATION SYSTEM | Invuity, Inc. | 2012-02-10 | 56 | 0 |
| K090070 | INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM | Invuity, Inc. | 2009-04-22 | 100 | 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