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

KPW — Predicate Candidate Screening

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

41 daysmedian FDA review time

134 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K093596	LUMOS, MODEL R 72B	Lumos, Inc.	2010-01-12	53
K062788	COLLIMATOR, MODEL M-38	Umi International	2006-12-28	101
K030487	R 72	Ralco S.R.L.	2003-08-01	168
K954310	BLA-800A	Toshiba Medical Systems	1995-10-18	33
K946320	R 302	Ralco S.R.L.	1995-05-11	134
K914184	P2020-8-0 BEAM-LIMITING DEVICE	Precise Optics	1991-11-27	70
K904587	DENSICOMP 250	L. Keroack Co.	1991-01-24	107
K904044	TF-63SA	Toshiba America Medical Systems, In.C	1990-11-29	86
K904489	EUREKA EXTENSION CYLINDERS	Eureka X-Ray Tube Corp.	1990-10-15	13
K820306	RALCO COLLIMATOR, AUTOMATIC RADIOGRAPHIC	Tecnomed, Inc.	1982-03-05	29
K820305	RALCO COLLIMATORS, MANUAL RADIOGRAPHIC	Tecnomed, Inc.	1982-03-04	28
K820119	PODIOSCOPE BY ARROW	Arrow X-Ray Corp.	1982-02-18	31
K811450	ALUMINUM FILTRATION SYSTEM	Wedge Filtration System	1981-07-02	41
K791504	AUTOMATIC POSITIVE BEAM COLLIMATOR	Dial-X Instruments, Inc.	1979-09-07	32
K781984	COLLIMATOR, HEART CONTOUR	Siemens Corp.	1978-12-04	10
K770335	COLLIMATOR, AUTOMATIC	Litton Medical Systems	1977-02-28	10

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