Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Genicon, LC — Predicate Candidate Screening

6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

153 daysmedian FDA review time

238 days90th percentile

6clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K030174	GENICON LAPAROSCOPES	Genicon, LC	2003-06-19	153	0
K030269	GENICON CLIP APPLIER	Genicon, LC	2003-03-20	52	0
K002542	REUSABLE CANNULA	Genicon, LC	2000-10-23	68	0
K993625	INSUFFLATION NEEDLE- 120MM, MODEL 900-200	Genicon, LC	2000-06-20	238	0
K991382	SHIELDEDTROCAR/CANNULA SYSTEM, MODEL 101-005-101	Genicon, LC	1999-07-15	85	0
K982472	GENICON TROCAR	Genicon, LC	1999-02-04	204	1

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