Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Igenics, Inc. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K963134 | DRAIN/SLIT SPONGE (NON-STERILE AND STERILE) | Igenics, Inc. | 1996-09-06 | 25 | 0 |
| K955527 | GENERAL USE SYNTHETIC SPONGE (STERILE) | Igenics, Inc. | 1996-02-05 | 63 | 0 |
| K955165 | SYNTHETIC SPONGE | Igenics, Inc. | 1996-02-05 | 84 | 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