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

JAC — Predicate Candidate Screening

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

73 daysmedian FDA review time

231 days90th percentile

18clearances measured

K-number	Device	Applicant	Decided	Review days
K942883	DIGITAL I.D. CAMERA	Miles Inc., Agfa Division	1994-09-30	105
K930752	CT/MRI TOPOGRAPHIC MARKER	I.Z.I. Corp.	1993-11-19	280
K932357	FUJI EC ID CAMERA	Fujifilm Medical System U.S.A., Inc.	1993-07-26	73
K925892	SOLSTICE XRAY RING MARKER PAD	Solstice Corp.	1993-05-18	182
K923533	ADMARK	Planmeca USA, Inc.	1993-03-04	231
K926404	KODAK X-OMATIC IDENTIFICATION CAMERA, MODEL 4 & 4L	Eastman Kodak Company	1993-03-04	73
K924345	RADIOGRAPHIC FILM MARKETING SYSTEM	Fischer Imaging Corp.	1992-11-27	92
K925332	BENNETT X-RAY ID PLUS	Bennett X-Ray Technologies	1992-11-27	37
K920031	KODAK X-OMATIC IDENT. CAMERA MAMMOGRAPHY UPGRADE	Eastman Kodak Company	1992-02-12	40
K915088	KODAK MIN-R IDENTIFICATION CAMERA	Eastman Kodak Company	1991-12-02	20
K913478	RADIOGRAPHIC FILM MARKING SYSTEM	Lorad Medical Systems, Inc.	1991-10-15	70
K911873	X-MARX	Macbrud Corp. Medical Div.	1991-07-19	81
K910354	DU PONT IDENTIFICATION CAMERA	Dupont Medical Products	1991-03-29	59
K890467	KODAK PORTABLE IDENTIFICATION CAMERA	Eastman Kodak Company	1989-02-16	16
K882519	X-RAY MARKER	Karlin Technology, Inc.	1988-08-09	53
K870565	KODAK X-OMATIC IDENT. CAMERA, MODELS 2 AND 2L	Eastman Kodak Company	1987-02-26	16
K870701	KODAK X-OMATIC IDENTIFICATION CAMERA DIGITAL	Eastman Kodak Company	1987-02-26	6
K852160	RADIOLOGICAL MARKING PEN	Truett Laboratories, Inc.	1985-07-18	140

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