Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
In Vitro Technologies, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
332 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K914685 | 866.5750 RADIOALLERGOSORBENT IMMUNLOGICAL TEST SYS | In Vitro Technologies, Inc. | 1992-09-14 | 332 | 0 |
| K904661 | IVT RAST TRACER | In Vitro Technologies, Inc. | 1990-11-29 | 48 | 0 |
| K875329 | IVT CENTRAL ALLERGY SCREEN | In Vitro Technologies, Inc. | 1988-04-07 | 99 | 0 |
| K875328 | IVT WESTERN ALLERGY SCREEN | In Vitro Technologies, Inc. | 1988-03-23 | 84 | 0 |
| K874169 | IVT NORTHEAST ALLERGY SCREEN | In Vitro Technologies, Inc. | 1988-01-11 | 90 | 0 |
| K874168 | IVT SOUTHEAST ALLERGY SCREEN | In Vitro Technologies, Inc. | 1988-01-11 | 90 | 0 |
| K870625 | IVT SOUTHWEST ALLERGY SCREEN | In Vitro Technologies, Inc. | 1987-05-01 | 77 | 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