Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Incutech, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
128 daysmedian FDA review time
276 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K960619 | MORE-L INJECTOR KIT PLUS | Incutech, Inc. | 1996-06-20 | 128 | 0 |
| K951870 | MORELL INJECTOR | Incutech, Inc. | 1996-01-22 | 276 | 0 |
| K942394 | SAFE VENT SYSTEM | Incutech, Inc. | 1995-01-27 | 253 | 0 |
| K941731 | EMPTY, SOLUTION TRANSFER CONTAINER WITH DETATCHABLE LEG SET | Incutech, Inc. | 1994-07-22 | 106 | 0 |
| K940258 | SOLUTION TRANSFER CONTAINER W/ATTACHED LEG SET (EMPTY) | Incutech, Inc. | 1994-03-28 | 66 | 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