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

IWZ — Predicate Candidate Screening

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

52 daysmedian FDA review time

102 days90th percentile

34clearances measured

K-number	Device	Applicant	Decided	Review days
K970154	KODAK EKTASIAN HG FILM (EHG-15)	Eastman Kodak Company	1997-04-04	78
K954200	VOXGRAM	Voxel	1995-09-29	23
K931604	3M MEDICAL DIAGNOSTIC VIDEOCASSETTE	3M Health Care, Ltd.	1993-07-21	111
K931605	3M MEDICAL DIAGNOSTIC SUPER VHS VIDEOCASSETTE	3M Health Care, Ltd.	1993-07-20	110
K920539	ORWO X-RAY FILM	Burkhart Roentgen Intl., Inc.	1992-06-30	146
K884827	KODAK DENTAL BARRIER PAC	Eastman Kodak Company	1989-01-30	73
K862944	KODAK CFT FILM SO-141	Eastman Kodak Company	1986-08-12	7
K862415	TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM	Parexel Intl. Corp.	1986-07-01	6
K860797	MEDICAL X-RAY FILM	India-America Trading Co.	1986-03-13	9
K844554	BELMONT AUTOPAN-PANORAMIC 098 CEPHALOMETRIC-RADIOG	Belmont Equipment Corp.	1985-02-21	92
K840806	FR MEDICAL X-RAY FILM	Fr Medical/Fr Chemicals	1984-04-24	60
K840698	POWERMAT VRP-1 X-RAY IMAGING	Powers Chemco, Inc.	1984-03-16	29
K834613	WILCOR-XR RP MEDICAL FILM	Cea America Corp.	1984-03-05	76
K834614	WILCOR-XR RP-L MEDICAL FILM	Cea America Corp.	1984-03-05	76
K834612	WILCOR-XR RP-OG MEDICAL FILM	Cea America Corp.	1984-02-27	69
K834611	SINGUL-XR RP NON SCREEN MED. FILM	Cea America Corp.	1984-02-21	63
K833234	KODAK T-MAT L FILM SO-387	Eastman Kodak Company	1983-10-28	46
K832504	CRONEX LO-DOSE MAMMOGRAPHY	E.I. Dupont DE Nemours & Co., Inc.	1983-09-12	53
K813005	KODAK CINEFLUOROGRAPHIC FILM SO-274	Eastman Kodak Company	1981-11-24	28
K811352	POLAROID TPX RADIOGRAPHIC FILM	Polaroid Corp.	1981-06-18	35
K802171	KODAK ORTHO L FILM	Eastman Kodak Company	1980-10-31	52
K800901	KODAK EKTASPEED DENTAL X-RAY FILM	Eastman Kodak Company	1980-05-20	32
K800134	HOPE MODEL 126, AUTO/PROCES., DEN. FLM	Hope Industries, Inc.	1980-05-02	102
K792517	KODAK X-OMAT RP FILM	Eastman Kodak Company	1980-01-09	34
K792178	KODAK CFN FILM SO-224	Eastman Kodak Company	1980-01-09	72
K792434	KODAK X-OMAT M20 PROCESSOR, MODEL 2	Eastman Kodak Company	1980-01-09	42
K792317	SR 301 MEDICAL X-RAY FILM	E.I. Dupont DE Nemours & Co., Inc.	1980-01-09	54
K792448	KODAK X-OMAT G FILM	Eastman Kodak Company	1980-01-09	40
K792435	KODAK X-OMAT M20 PROCESSOR, MODEL 1	Eastman Kodak Company	1980-01-09	42
K792293	KODAK ORTHO G FILM	Eastman Kodak Company	1980-01-09	55
K791360	KODAK ORTHO M FILM	Eastman Kodak Company	1979-09-04	42
K790629	KODAK GRAY TONE IMAGING FILM	Eastman Kodak Company	1979-04-23	25
K771681	ORTHO H FILM	Eastman Kodak Company	1977-09-14	8
K771223	GRAY TONE IMAGING FILM	Eastman Kodak Company	1977-07-14	9

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