Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Innervision, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
154 daysmedian FDA review time
207 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K992345 | CHRISTOUDIAS SLIM TIP ELECTRODE INSERT | Innervision, Inc. | 1999-09-10 | 89 | 0 |
| K991877 | MACMED PAEDIATRIC INTRAMEDULLARY NAIL | Innervision, Inc. | 1999-08-06 | 65 | 0 |
| K982428 | CHRISTOUDIAS GAUZE DISSECTOR (LAPAROSCOPIC HAND INSTRUMENT) | Innervision, Inc. | 1998-10-09 | 88 | 0 |
| K940731 | INNERVISION INC. CANNULA/TROCAR,MULTIPLE TYPES | Innervision, Inc. | 1994-09-13 | 207 | 0 |
| K940750 | INNERVISION,INC. LAPAROSCOPIC ELECTRODES | Innervision, Inc. | 1994-08-23 | 186 | 0 |
| K940718 | INNERVISION INC. LAPAROSCOPIC HAND INSTRUMENTS | Innervision, Inc. | 1994-07-22 | 154 | 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