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

Morax — Predicate Candidate Screening

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

188 daysmedian FDA review time

236 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K033277	HYDRAGEL CSF ISOFOCUSING KITS	Morax	2003-11-04	25	0
K012789	MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123	Morax	2002-01-17	150	0
K992148	HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS	Morax	1999-12-29	188	0
K991362	HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E),	Morax	1999-06-21	68	1
K990250	HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/H	Morax	1999-06-18	143	0
K974854	HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, H	Morax	1998-10-07	282	0
K981048	HYDRAGEL 6 CSF KIT	Morax	1998-10-07	201	0
K972591	HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRA	Morax	1998-03-04	236	0
K972015	HYDRAGEL 7,15,30, CHOL-HDL KIT	Morax	1997-10-27	150	0
K963844	HYDRAGEL 15 HB A1C KIT	Morax	1997-04-22	209	0
K960029	HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,3	Morax	1996-07-17	197	0
K960669	HYDRAGEL IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF,	Morax	1996-07-12	143	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