Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

HME — Predicate Candidate Screening

16 FDA 510(k) clearances under this product code; the 50 most recent screened below.

38 daysmedian FDA review time

161 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K930449	MARCO, MARCOTILT, ENCORE AND CUSTOM CHAIR	Marco Ophthalmic, Inc.	1993-07-06	161
K914416	BREATH-EASY, MODIFICATION	Icor AB	1992-06-23	272
K894018	RELIANCE(R) 6200 EXAMINATION CHAIR	Reliance Medical Products, Inc.	1989-09-12	98
K870112	STORZ ENT/OPHTHALMIC MAXI CHAIR	Storz Instrument Co.	1987-02-12	31
K864494	MODEL 6500 OPTHALMIC CHAIR	Koken Mfg Company, Inc.	1986-12-15	31
K864574	MAC 150E OPTHALMIC CHAIR	Koken Mfg Company, Inc.	1986-12-15	25
K863728	THE ERGOSYSTEM CHAIR	Charles D. Bell, Inc.	1986-10-31	38
K863008	-OM WEST 2000 GNATUS CHAIR	Sds Dental, Inc.	1986-09-24	47
K853743	TECHNA VISION, INC. ELECTRIC CHAIR	Techna Vision	1985-10-17	41
K853149	RELIANCE 1000, RELIANCE 1500, RELIANCE 2000	F. & F. Koenigkramer	1985-09-05	38
K853150	RELIANCE 6100	F. & F. Koenigkramer	1985-09-05	38
K853151	RELIANCE 5000	F. & F. Koenigkramer	1985-09-05	38
K842045	WOODLYN CLASSIC EXAM. CHAIR	Woodlyn, Inc.	1984-06-19	29
K833539	DOWING OPHTHALMIC CHAIR AC-POWERED	Vision Health Technology	1984-03-05	152
K801638	A O CUSTOM II CHAIR AND STAND	American Optical Corp.	1980-08-13	27
K781801	MAXI-CHAIR	Surgical Mechanical Research, Inc.	1978-11-03	11

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