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

2010 — Predicate Candidate Screening

2,807 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.

110 daysmedian FDA review time

297 days90th percentile

2,000clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K103668	BNX FINE NEEDLE ASPIRATION SYSTEM	Boston Endoscopic Engineering	2010-12-30	14	5
K102931	G-CINCH SUTURE GRASPER	Usgi Medical	2010-12-30	87	0
K103239	IRRIGATION SYSTEM	United States Endoscopy Group, Inc.	2010-12-30	58	1
K101450	CANTATA MICROCATHETER	Cook, Inc.	2010-12-30	220	0
K090105	LUPOTEK KCT	R2 Diagnostics, Inc.	2010-12-30	714	0
K102616	NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE	Smart Medical Systems , Ltd.	2010-12-30	111	0
K103412	AXIOM FASCIAL CLOSURE SYSTEM	Axiom Technology Partners, LLC	2010-12-30	38	0
K102663	AED RESECTOSCOPE	National Advanced Endoscopy Devices, Inc.	2010-12-30	106	0
K103153	VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORON	Abbott Vascular-Cardiac Therapies	2010-12-30	77	20
K103122	C-MAX, C-MAX U1, C-MAX U1 160KG, C-MAX U2, C-MAX U2 160KG, S	Aat Alber Antriebstechnik GmbH	2010-12-30	70	0
K103272	ZENIUS SPINAL SYSTEM	Medyssey Co, Ltd.	2010-12-29	54	0
K103097	INFRARED EAR THERMOMETER	Radiant Innovation, Inc.	2010-12-29	70	0
K102279	INCU I	Atom Medical Corporation	2010-12-29	140	0
K103667	SAPPHIRE ST PORTABLE DIODE LASER	Den-Mat Holdings, LLC	2010-12-29	14	0
K100993	INCLUSIVE TITANIUM ABUTMENTS FOR ASTRA TECH OSSEOSPEED IMPLA	Prismatik Dentalcraft, Inc.	2010-12-28	263	0
K101837	ACL TIGHTROPE DOUBLE BUNDLE	Arthrex, Inc.	2010-12-28	180	0
K102746	MIRAGE FX	Resmed, Ltd.	2010-12-28	96	0
K102210	LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPH	Lin-Zhi International, Inc.	2010-12-28	145	0
K103608	I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND	Ellex, Inc.	2010-12-27	18	0
K103583	DC-7 DIAGNOSTIC ULTRASOUND SYSTEM	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2010-12-27	20	0
K102572	IYUNNI 3ID SUPRAPUBIC CYSTOSTOMY TUBE KIT	Sainath Intellectual Properties, LLC	2010-12-27	110	0
K102937	OSTEOPHIL BETA-TCP	Cytophil, Inc.	2010-12-27	84	0
K103359	FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK)	C.R. Bard, Inc.	2010-12-27	41	0
K101294	PT2 VARIAN PROTON THERAPY SYSTEM	Varian Medical Systems, Oncology Systems	2010-12-27	231	0
K103193	DOSEVIEW 3D	Standard Imaging, Inc.	2010-12-27	59	0
K102835	VITAL SIGNS MONITOR	Edan Instruments, Inc.	2010-12-27	89	0
K102408	DIGITAL DIAGNOSTIC X-RAY SYSTEM	DRGEM Corporation	2010-12-27	126	0
K100932	INCLUSIVE MINI IMPLANT	Prismatik Dentalcraft, Inc.	2010-12-27	266	0
K102595	MEDISTIM VERIQC SYSTEM	Medi-Stim Asa	2010-12-27	109	1
K103357	LIFEBRIDGE	Lifebridge Medizintechnik AG	2010-12-27	41	0
K103303	CROSSTEX SURGICAL EARLOOP MASK- WHITE, CROSSTEX SURGICAL EAR	Crosstex International, Inc.	2010-12-23	44	0
K101723	COMPACT WHEELCHAIR PLATFORM	Design Specific Fletcher	2010-12-23	188	0
K102364	NYDIAG 200	Interacoustics A/S	2010-12-23	125	0
K102452	DEFOGGING AND CLEANING SOLUTION- FLO-X	Minimally Invasive Devices, LLC	2010-12-23	118	0
K103406	MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS	Kimberly-Clark Corp.	2010-12-23	34	2
K102910	MODEL LUNA MANUAL WHEELCHAIR	P.D.G., Inc.	2010-12-23	83	0
K102134	MODEL LA-1200 MULTI-CHANNEL LASER THERAPY SYSTEM	United Integrated Services Co., Ltd.	2010-12-23	147	0
K103235	ERBEFLO 2 DISPOSABLE TUBING SYSTEM	Erbe USA, Inc.	2010-12-23	51	0
K100715	AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5	Aalto Scientific, Ltd.	2010-12-23	286	0
K101522	ULTRA SEAL STERILE LUBRICATING JELLY	Ultra Seal Corporation	2010-12-23	204	0
K103437	US ENDOSCOPY CYTOLOGY BRUSH	United States Endoscopy Group, Inc.	2010-12-23	30	1
K094030	FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 S	Cas Medical Systems, Inc.	2010-12-23	358	0
K102817	POWDER-FREE VINYL PATIENT EXAMINATION GLOVES	Hebei Hongtai Plastic Products Co., Ltd.	2010-12-23	86	0
K103221	ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5	Roche Diagnostics	2010-12-23	52	0
K101427	AUDIT MICROCV HS-CRP LINEARITY SET	Aalto Scientific, Ltd.	2010-12-23	216	0
K103342	3.0T METAFLEXCOIL	Neocoil, LLC	2010-12-23	38	0
K103049	TSRH SPINAL SYSTEM	Medtronic Sofamor Danek	2010-12-23	69	0
K102819	POWDER-FREE VINYL PATIENT EXAMINATION GLOVES	Hebei Hongtai Plastic Products Co., Ltd.	2010-12-23	86	0
K102837	HIROLLER ELEVATING WHEELCHAIR	Max Mobility, LLC	2010-12-23	85	0
K102808	MI VARNISH	GC America, Inc.	2010-12-22	85	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