Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Genicon — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
114 daysmedian FDA review time
317 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K132375 | GENISTRONG SINGLE-USE SPECIMEN RETRIEVAL BAG | Genicon | 2014-06-12 | 317 | 1 |
| K100090 | IMPLANTABLE CLIP | Genicon | 2010-02-02 | 21 | 0 |
| K061417 | GENICON DISPOSABLE ELECTROSURGICAL INSTRUMENTATION, MODEL 53 | Genicon | 2006-10-10 | 141 | 0 |
| K041967 | GENICON SUCTION IRRIGATION SYSTEM | Genicon | 2004-11-12 | 114 | 0 |
| K041968 | GENICON BIPOLAR FORCEPS MODEL # 600-005-005 | Genicon | 2004-11-03 | 105 | 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