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

IZJ — Predicate Candidate Screening

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

50 daysmedian FDA review time

125 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K024085	CCD CAMERA, MODEL PKP-06000-000	Perkins Electronics Co.	2003-03-11	90	0
K972130	DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER,	Fairmontmedical	1997-10-09	125	0
K945580	DSP OPTION	Philips Medical Systems (Cleveland), Inc.	1995-01-30	77	0
K920793	PHILIPS DSI SYSTEM RELEASE 3.2	Philips Medical Systems, Inc.	1992-07-17	147	2
K896615	CINE CAMERA CONTROL MODEL PK2037	Perkins Mfg. Co.	1990-01-04	44	0
K881688	DTV-4114 FLUOROSCOPIC TELEVISION CAMERA	Adac Laboratories	1988-05-18	29	0
K853983	CANON X-RAY 35MM CINE CAMERA CSI-35	Canon USA, Inc.	1985-10-16	19	0
K812613	VIDICAM 200	Diversified P.A.	1981-12-08	84	0
K810191	SIRCAM 103	Siemens Corp.	1981-02-26	34	0
K810072	105MM ROLL FILM FLUOROGR. CAMERA, #105	Scientex Corp.	1981-02-12	30	0
K802132	105MM SPOT FILM CAMERA	Instrumentation Camera, Inc.	1980-10-23	50	0
K792394	SIRCAM 106	Siemens Corp.	1979-12-20	24	0

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