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

ETF — Predicate Candidate Screening

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

34 daysmedian FDA review time

88 days90th percentile

32clearances measured

K-number	Device	Applicant	Decided	Review days
K953457	JEDMED SPECTRUM ENT CABINET	Jedmed Instrument Co.	1995-08-11	21
K945395	PREMIER MIRROR WARMER	Premier Dental Products Co.	1995-01-18	76
K932470	LANGGASSE 90	Happersberger Otopront GmbH	1993-08-25	97
K911901	MAXI CABINET OPTIONAL BUILT IN S6000 LIGHT SOURCE	Stortz	1991-07-26	88
K910781	#491 POWER OTOLARYNGOLY CH/#498 PROCED CTR & ACCES	Midmark Corp.	1991-05-15	79
K910243	MOBILE TREATMENT CART	Jedmed Instrument Co.	1991-04-17	85
K896273	SYSTEMA ENT CABINET	Jedmed Instrument Co.	1990-01-26	88
K896298	JEDMED S CHAIR	Jedmed Instrument Co.	1990-01-26	88
K881958	JEDMED MAXIM ENT CABINET	Jedmed Instrument Co.	1988-07-15	66
K860940	MICROMEDICS STERILE, DISPOSABLE ENT EXAM KIT	Micromedics, Inc.	1986-05-02	51
K855021	LARYNGEAL MIRROR PRE-WARMER	Jedmed Instrument Co.	1986-03-20	94
K843046	RELIANCE TREATMENT CABINET	F. & F. Koenigkramer	1984-09-27	56
K833882	INSTRUMENT CABINET	Jedmed Instrument Co.	1984-01-27	79
K823226	SN-100 DOCTOR'S ROUND	Kells Medical, Inc.	1982-11-22	24
K822252	ENT TREATMENT UNITS	Kelleher Corp.	1982-11-22	116
K822531	MULTIPLE, ENT CABINET #448	Midmark Corp.	1982-09-28	36
K822530	MULTIPLE, ENT CHAIR #418	Midmark Corp.	1982-09-14	22
K822016	NAGASHIMA SN-SP UNIT AND CHAIR	Kelleher Corp.	1982-09-14	68
K813490	VERSION OF A CLOSED-FLOW SYS. CALORIC	Thomas M. Foti, M.D.	1982-01-07	34
K810148	ATMOSET	Jedmed Instrument Co.	1981-02-17	27
K802712	ENTERMED ENTUNIT	Jedmed Instrument Co.	1980-11-26	26
K801738	NOBLE MEDEL ENT TREATMENT UNIT	Jedmed Instrument Co.	1980-08-13	19
K801739	NOBLE MODEL DOUBLESIDED TREATMENT UNIT	Jedmed Instrument Co.	1980-08-13	19
K801742	NEW FINE MODEL ENT TREATMENT UNIT	Jedmed Instrument Co.	1980-08-13	19
K801741	PRETTY MODEL ENT TREATMENT UNIT	Jedmed Instrument Co.	1980-08-13	19
K801740	TREATMENT UNIT FOR DOCTOR'S ROUNDS	Jedmed Instrument Co.	1980-08-13	19
K800756	DUNRICH TABLES	Dunrich, Inc.	1980-04-16	12
K800526	SMR H-CHAIR	Surgical Mechanical Research, Inc.	1980-03-18	11
K791936	ATMOS ENT CABINET PRACTICA 2	Jedmed Instrument Co.	1979-10-30	33
K791934	ATMOS ENT TREATMENT SYSTEM SERVANT 3	Jedmed Instrument Co.	1979-10-30	33
K791935	ATMOS ENT CABINET PRACTICA 3	Jedmed Instrument Co.	1979-10-30	33
K782064	TABLE, EXAMINING-TWO EIGHTY	Amsco Co.	1978-12-28	15

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