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

KPX — Predicate Candidate Screening

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

41 daysmedian FDA review time

144 days90th percentile

26clearances measured

K-number	Device	Applicant	Decided	Review days
K945635	TRANS X-1000	Canon USA, Inc.	1995-02-01	77
K935157	ARTICULATED, LAPAROSCOPIC, AND SIDE-VIEWING T-PROBES	Regulatory Consultants TO the Medical Device Indus	1994-08-09	285
K934850	NUCLEAR ASSOCIATES PERSONNEL PROTECTIVE SHIELDS	Victoreen, Inc.	1993-11-22	41
K933035	BCM-600TX	B C Medical , Ltd.	1993-10-08	108
K925598	BUCKYMATIC AUTOMATIC CHEST FILM CHANGER	Acoma Medical Imaging, Inc.	1993-02-01	88
K924423	MWX-7440 HIGH SPEED BUCKY	Midwest X-Ray Equipment Co.	1993-01-15	136
K925169	SHIMADZU RADIOGRAPJHIC STAND BR-100	Shimadzu Medical Systems	1992-12-03	51
K920196	OX-600	Stardard X-Ray Sales Co.	1992-10-14	273
K922483	DU PONT COMPACT DAYLIGHT SYSTEM 2000	E.I. Dupont DE Nemours & Co., Inc.	1992-09-11	107
K905789	FRANKLIN 9000 WALL STAND	Mallinckrodt Group, Inc.	1991-05-20	144
K902761	AUTOMATIC CASSETTE LOADER	Mallinckrodt Group, Inc.	1990-10-09	106
K903576	PUCK 90M	Elema-Schonander, Inc.	1990-09-04	27
K870048	ADDITIONAL MODEL TO CANON UNIVERSAL STAND	Canon USA, Inc.	1987-01-12	6
K862575	UNIVERSAL STAND FOR FILM CHANGER	Canon USA, Inc.	1986-07-14	7
K853928	UNIVERSAL STAND FOR FILM CHANGER	Canon USA, Inc.	1985-10-28	34
K851067	CANON X-RAY FILM CHANGER CFC-U1	Canon USA, Inc.	1985-05-21	64
K842911	PUCK U & UD CUTFILM CHANGERS	Elema-Schonander, Inc.	1984-08-21	29
K820117	AUTOMATIC TRAY (ACT I & ACT II	Burbury & Cutter Ind., Inc.	1982-02-18	31
K811967	CP-625 SEE-THRU FILM CHANGER	Philips Medical Systems (Cleveland), Inc.	1981-08-13	34
K812024	XEROX 128 CASSETTE CHANGER	Xerox Medical Systems	1981-08-13	24
K801950	BCM-600 MINI-SIX EXTRA LG. FIELD ANGIO	B C Medical , Ltd.	1980-10-03	49
K800751	RADX VENT-AL MECHANICAL RESPORATOR	Radx Corp.	1980-05-08	34
K792068	MEMCO 300 FILM CHANGER	Memco, Inc.	1979-11-16	32
K791811	SPECTRUM AUTOMATIC CHEST UNIT MODEL C	Spectrum X-Ray Corp.	1979-10-26	38
K770836	ULTIMAT L4 X L4, LIEBEL-FLARSHEIM	Mallinckrodt Group, Inc.	1977-05-26	20
K760279	X-RAY FILM, CONVEY OR SYSTEM	Mallinckrodt Group, Inc.	1976-08-13	21

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