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

Rhigene, Inc. — Predicate Candidate Screening

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

62 daysmedian FDA review time

155 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K040711	MESACUP TEST PR-3	Rhigene, Inc.	2004-04-02	15
K040586	MESACUP TEST MPO, MODEL 11053	Rhigene, Inc.	2004-03-22	17
K040200	MESACUP-2 TEST CENP-B	Rhigene, Inc.	2004-03-04	35
K033528	MESACUP-2 TEST JO-1, MODEL 10756	Rhigene, Inc.	2003-12-22	45
K031308	RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760	Rhigene, Inc.	2003-09-26	155
K022017	RHIGENE MESACUP-2 TEST RNP, MODEL M7741	Rhigene, Inc.	2002-08-14	55
K022018	RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560	Rhigene, Inc.	2002-07-05	15
K011068	RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L	Rhigene, Inc.	2002-04-11	367
K000336	RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E	Rhigene, Inc.	2000-06-09	127
K000749	RHIGENE MESACUP2 TEST- SSA	Rhigene, Inc.	2000-05-09	62
K000755	RHIGENE MESACUP2 TEST- SM	Rhigene, Inc.	2000-05-09	62
K000750	RHIGENE MESACUP2 TEST- SCL-70	Rhigene, Inc.	2000-05-09	62
K000751	RHIGENE MESACUP2 TEST- SSB	Rhigene, Inc.	2000-05-09	62
K000752	RHIGENE MESACUP2 TEST- RNP	Rhigene, Inc.	2000-05-09	62
K994071	RHIGENE ANA ELISA TEST SYSTEM	Rhigene, Inc.	2000-01-18	47

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