Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
DAY · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K942326 | HUMAN C5 RID KITS | Jay H. Geller | 1995-08-24 | 468 | 0 |
| K950102 | HUMAN C-5 RADIAL IMMUNODIFFUSION KIT | Kent Laboratories, Inc. | 1995-04-10 | 89 | 0 |
| K772075 | RADIAL IMMUNODIFFUSION KIT-COMPLEMENT | Gelman Instrument Co. | 1978-02-03 | 92 | 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