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

2011 — Predicate Candidate Screening

3,124 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.

111 daysmedian FDA review time

313 days90th percentile

2,000clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K111149	HANAROSTENT BILIARY (NNN)	M.I.Tech Co., Ltd.	2011-12-30	249	0
K111985	MYOGUIDE SYSTEM MODEL 8008	Intronix Technologies Corp.	2011-12-30	171	0
K113337	VISIA DYNAMIC REVIEW	MeVis Medical Solutions AG	2011-12-30	46	0
K111403	MASIMO RAINBOW SET PRONTO-7 PULSE CO-OXIMETER AND ACCESSORIE	Masimo Corporation	2011-12-30	225	0
K112522	FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM	Flexible Stenting Solutions, Inc.	2011-12-30	121	1
K111068	STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND	Skeletal Dynamics, LLC	2011-12-30	256	0
K112944	FRESENIUS MEDICAL TREATMENT CHAIR T688 SERIES	Fresenius Medical Care South Asia Pacific Pty , Ltd.	2011-12-30	87	0
K113373	DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL	Siemens Healthcare Diagnostics, Inc.	2011-12-30	44	0
K102999	TRIMOTION INJECTOR	Kaneka Corp.	2011-12-29	447	0
K112778	SMART SEGMENTATION-KNOWLEDGE BASED CONTOURING	Varian Medical Systems	2011-12-29	94	0
K113342	SOMATOM DEFINITION FLASH	Siemens Medical Systems, Inc.	2011-12-29	45	1
K112543	WALLFLEX BILIARY TRANSHEPATIC UNCOVERED STENT SYSTEM, WALLFL	Boston Scientific Corporation	2011-12-29	119	0
K113269	ELITTECH CLINICAL SYSTEMS ALP IFCC SL	Elitechgroup	2011-12-29	55	0
K113630	DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGA	Rayence Co., Ltd.	2011-12-29	21	0
K113680	SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT	Soma Access Systems, LLC	2011-12-29	14	1
K113559	LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IM	Ldr Spine USA, Inc.	2011-12-29	28	0
K112914	VPAP TX	Resmed, Ltd.	2011-12-29	87	0
K113381	MYSONO U6 DIAGNOSTIC ULTRASOUND SYSTEM	Samsung Medison Co., Ltd.	2011-12-29	43	0
K113690	GE LOGIQ I, LOGIQ E AND VIVID E	GE Healthcare	2011-12-29	14	1
K110639	ENDOWRIST ONE VESSEL SEALER	Intuitive Surgical, Inc.	2011-12-28	299	2
K112572	GEISTLICH COMBI-KIT COLLEGEN	Geistlich Pharma AG	2011-12-28	113	0
K113283	NNC CEMENTABLE ABUTMENT STRAIGHT,15 DEGREE ANGLE, TYPE A ,15	Straumann USA	2011-12-28	51	0
K103573	ARTS2 SPINAL FIXATION SYSTEM	Advanced Medical Technologies	2011-12-28	387	0
K112080	PRESERVE HIP STEM	Wrightmedicaltechnologyinc	2011-12-28	160	0
K111618	AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O	Natus Medical Incorporated	2011-12-28	201	0
K111671	SEASPINE MONOPOLAR PROBE SYSYEM	Seaspine, Inc.	2011-12-28	196	0
K113040	CERAMIR CROWN & BRIDGE	Doxa Dental AB	2011-12-28	77	0
K113317	LIFECHOICE OXYGEN CONCENTRATOR	Inova Labs, Inc.	2011-12-28	48	0
K111776	DELTAVIEW MODEL 2.1	Riverain Medical Group,Llc	2011-12-28	188	0
K112575	GEISTLICH PERIO-SYSTEM COMBI-PACK , GEISTLICH BIO-GIDE PERIO	Geistlich Pharma AG	2011-12-27	112	0
K112923	SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEM	Suspension Orthopaedic Solutions, LLC	2011-12-27	85	0
K112822	SLEEPSTRIP II	S.L.P. , Ltd.	2011-12-27	90	0
K112546	O_TWO CPAP SYSTEM	O-Two Medical Technologies, Inc.	2011-12-27	117	0
K112933	ACCESS THYROGLOBULIN ANITBODY	Beckman Coulter, Inc.	2011-12-27	85	2
K112387	PROCEDURE REHEARSAL STUDIO(TM)	Simbionix , Ltd.	2011-12-27	131	0
K112499	BIOMERIX COMPOSITE SURGICAL MESH	Biomerix Corporation	2011-12-23	115	0
K112567	BIOMERIX ASSURE	Biomerix Corporation	2011-12-23	112	0
K112352	GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT	Bionostics, Inc.	2011-12-23	129	0
K111673	1.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL	Invivo Corporation	2011-12-23	191	0
K112901	EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONIT	Eps Bio Technology Corp.	2011-12-23	81	0
K112664	ZAVATION IBF SYSTEMS	Zavation, LLC	2011-12-23	101	0
K112412	AU5800(R) CHEMISTRY ANALYZER	Beckman Coulter, Inc.	2011-12-23	123	7
K112799	MED-RX EXTENSION SET WITH T-CONNECTOR	Benlan, Inc.	2011-12-23	87	0
K111680	DR. GREENSBURG'S HYBRID	Always More Marketing, Inc.	2011-12-23	191	0
K110726	ROCHE ACETAMINOPHEN ASSAY	Roche Diagnostics	2011-12-23	282	0
K113109	STRYKER RESORBABLE FIXATION SYSTEM	Stryker	2011-12-23	64	0
K112789	EASY TOUCH	Mhc Medical Products, LLC	2011-12-23	88	0
K113443	21.3 INCH (54 CM) MONOCHROME LCD MONITOR MS23I2 (ML21023)	Totoku Electric Co., Ltd.	2011-12-23	32	0
K110717	KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM	Konica Minolta Medical & Graphic, Inc.	2011-12-23	283	0
K110313	TINA-QUANT HBA1C GEN.2	Roche Diagnostics	2011-12-23	324	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