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

Jeneric Ind. — Predicate Candidate Screening

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

55 daysmedian FDA review time

83 days90th percentile

25clearances measured

K-number	Device	Applicant	Decided	Review days
K862822	REXILLIUM N. B. F.	Jeneric Ind.	1986-09-02	39
K862926	SURGICAL VITEX	Jeneric Ind.	1986-08-29	28
K854878	H40 BASE METAL ALLOY	Jeneric Ind.	1986-01-30	55
K844122	RX CBG	Jeneric Ind.	1985-01-09	78
K844123	RX CBY	Jeneric Ind.	1985-01-09	78
K840563	RX C & B 20	Jeneric Ind.	1984-05-01	83
K840561	RX ELAN	Jeneric Ind.	1984-05-01	83
K840562	REX V	Jeneric Ind.	1984-04-13	65
K834560	VITEX P.D.A	Jeneric Ind.	1984-02-27	61
K833774	NATURELLE II & LITE II-N72-N74-L	Jeneric Ind.	1984-01-24	89
K833736	GOLD-PALLADIUM-SILVER BASED CAST/ALLOY	Jeneric Ind.	1983-12-29	65
K833143	REXILLIUM III	Jeneric Ind.	1983-12-08	84
K833145	ZENITH	Jeneric Ind.	1983-11-28	74
K833052	RXG	Jeneric Ind.	1983-11-14	68
K833053	Y CERAMIC	Jeneric Ind.	1983-11-14	68
K833049	PALLADENT	Jeneric Ind.	1983-10-28	51
K833144	REX ALLOY	Jeneric Ind.	1983-10-28	43
K833050	RX 90	Jeneric Ind.	1983-10-28	51
K823008	NOVAREX	Jeneric Ind.	1982-11-03	22
K822951	SPHEREX E.C.T.	Jeneric Ind.	1982-10-26	22
K822947	NEPTUNE	Jeneric Ind.	1982-10-26	22
K822949	RX SFC	Jeneric Ind.	1982-10-22	18
K822950	RX UNIVERSAL	Jeneric Ind.	1982-10-22	18
K822948	RX BIOCAST	Jeneric Ind.	1982-10-22	18
K820057	LUXOR PORCELAIN	Jeneric Ind.	1982-03-02	50

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