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

Medicon, Inc. — Predicate Candidate Screening

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

65 daysmedian FDA review time

314 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K962087	SERVOTRONIC EC100 SYSTEM	Medicon, Inc.	1997-04-23	330
K952168	TITANIUM MANDIBULAR FRACTURE SYSTEM	Medicon, Inc.	1995-06-22	45
K850855	TENS GB1001 DEVICE	Medicon, Inc.	1986-01-09	314
K850852	INFRARAX DEVICE	Medicon, Inc.	1985-08-21	173
K844702	GAUZE ASORBABLE	Medicon, Inc.	1985-04-01	119
K844573	ABSORBABLE GAUZE PRODUCTS	Medicon, Inc.	1985-03-05	102
K844574	WHEELCHAIRS	Medicon, Inc.	1985-02-21	90
K844704	CAPS (O.R. NURSE, SURGICAL)	Medicon, Inc.	1985-01-10	38
K844703	GOWNS, SURGICAL	Medicon, Inc.	1985-01-10	38
K844705	SHOE COVERS	Medicon, Inc.	1985-01-10	38
K840034	VACUUM STRETCHER IMMOBILIZER	Medicon, Inc.	1984-02-27	53
K823197	MODEL 8300 TESTER	Medicon, Inc.	1982-12-30	65
K812873	MEDICON #8200 AMS	Medicon, Inc.	1981-11-16	33
K810153	VENTILATORY EFFORT MONITOR	Medicon, Inc.	1981-02-09	19

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