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

Sorex Medical · Predicate Candidate Screening

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

105 daysmedian FDA review time

602 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K923843	FOGLESS	Sorex Medical	1994-03-25	602
K913036	PLUME MASTER	Sorex Medical	1991-09-06	59
K911070	PICC-FIX	Sorex Medical	1991-07-05	116
K911150	SOREX SAFE-AIR	Sorex Medical	1991-06-28	105
K910315	PICC INSERTION KIT/P.I.C. & PICC EXCHANG KIT/P.E.K	Sorex Medical	1991-04-05	71
K905572	EDLICH WOUND MANAGEMENT TRAY	Sorex Medical	1991-03-12	90
K903740	TRACH-EZE	Sorex Medical	1990-12-06	112
K902410	MEDICAL PROCEDURE TRAY	Sorex Medical	1990-11-20	173
K885136	GRAFT GUARD	Sorex Medical	1989-02-06	53

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