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

ODA — Predicate Candidate Screening

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

142 daysmedian FDA review time

255 days90th percentile

18clearances measured

K-number	Device	Applicant	Decided	Review days
K232406	KARL STORZ OR1™ SCB CONTROL (WU300)	Karl Storz SE & CO. KG	2023-10-03	54
K221929	Smith+Nephew INTELLIO Tablet	Smith+Nephew	2022-09-06	67
K203566	Tablet Application	Smith & Nephew	2021-05-13	157
K192876	INTELLIO Tablet Application	Smith & Nephew	2020-02-27	142
K153205	IDSS ForceTriad Control Module	Black Diamond Video, Inc.	2016-08-01	271
K151282	core nova Complete Operating Room Endoscopy	Richard Wolf Medical Instruments Corp.	2016-01-12	243
K111165	KARL STORZ SCB / COVIDIEN FORCETRIAD INTERFACE MODULE	KARL STORZ Endoscopy-America, Inc.	2012-01-06	255
K102763	SYSTEMS INTEGRATION	Olympus Medical Systems Corporation	2011-02-15	144
K100345	SYSTEMS INTEGRATION MODEL: ENDOALPHA	Olympus Medical Systems Corporation	2010-03-22	45
K083598	KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION	KARL STORZ Endoscopy-America, Inc.	2009-05-29	175
K080410	KARL STORZ SCB/CONMED ESU INTERFACE MODULE, MODEL 20091522	KARL STORZ Endoscopy-America, Inc.	2008-04-09	55
K070827	KARL STORZ SCB INTERFACE CONTROL, MODEL 20090120	KARL STORZ Endoscopy-America, Inc.	2007-05-22	57
K051613	MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOAL	Olympus Medical Systems Corporation	2005-08-15	59
K041912	SCB/VALLEYLAB FORCE FX INTERFACE UNIT	KARL STORZ Endoscopy-America, Inc.	2004-10-25	102
K020255	RIWO NET OPERATING OPERATING CONTROL SYSTEM, MODEL #5590	Richard Wolf Medical Instruments Corp.	2002-09-18	237
K022270	MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOAL	Olympus Optical Co., Ltd.	2002-08-14	30
K994231	SIEMENS INTEGRATED OPERATING SYSTEM (SIOS)	Siemens Medical Corp.	2000-08-10	238
K981993	OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA	The Olympus Optical Co.	1998-08-21	74

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