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

Sopro — Predicate Candidate Screening

25 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

87 daysmedian FDA review time

278 days90th percentile

25clearances measured

K-number	Device	Applicant	Decided	Review days
K223470	C50	Sopro	2023-12-14	392
K121685	SOPROCARE	Sopro	2013-03-12	278
K103813	SOPRO 281	Sopro	2011-03-22	83
K092329	SOPIX 2	Sopro	2010-07-20	350
K092583	SOPROLIFE	Sopro	2010-01-13	145
K082796	SOPRO 184 CAMERA	Sopro	2009-04-01	190
K080122	SOPRO 670 ARTHROSCOPIC PUMP	Sopro	2008-07-11	176
K070783	SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR	Sopro	2007-12-13	267
K072912	SOPRO 225 DUAL HALOGEN LIGHT SOURCE	Sopro	2007-11-16	35
K070102	SOPRO 162 CAMERA	Sopro	2007-02-20	41
K031593	SOPRO 61D	Sopro	2003-09-16	118
K020915	SOPRO LIGHT SOURCES AND ACCESSORIES	Sopro	2002-06-14	85
K020270	SOPRO 367D 3CCD FULL DIGITAL ENDOSCOPY CAMERA	Sopro	2002-03-14	45
K013090	SOPRO 67D OPERATING ROOM CAMERA	Sopro	2001-12-13	87
K012505	SOPRO595 INTRA ORAL CAMERA	Sopro	2001-10-05	63
K000422	S57D DIGITAL OPERATING ROOM CAMERA	Sopro	2000-03-31	51
K000423	S52D DIGITAL VIDEO LAPAROSCOPE	Sopro	2000-03-31	51
K000424	S51D DIGITAL ENDOSCOPY CAMERA	Sopro	2000-03-31	51
K990948	S575 INTRAORAL DOCKING DENTAL CAMERA	Sopro	1999-04-21	30
K983625	S555 INTRAORAL DENTAL CAMERA	Sopro	1999-01-11	88
K973794	S-57 VIDEO IMAGING SYSTEM	Sopro	1998-01-02	88
K973796	S-41 &41S VIDEO IMAGING SYSTEM	Sopro	1998-01-02	88
K973795	S-52 ELECTRONIC VIDEO LAPAROSCOPE	Sopro	1998-01-02	88
K973798	S-357 VIDEO IMAGING SYSTEM	Sopro	1997-12-03	58
K972540	S-357 VIDEO IMAGING SYSTEM	Sopro	1997-09-18	73

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