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

2001 — Predicate Candidate Screening

3,494 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.

70 daysmedian FDA review time

202 days90th percentile

2,000clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K013556	MONOJECT PREFILL HEPARIN LOCK FLUSH SYRINGE	Tyco Healthcare	2001-12-31	67	0
K014091	STRYKER PAINPUMP	Stryker Corp.	2001-12-31	19	0
K012029	REMEDY MODEL 2Z12	Apollo Corp.	2001-12-31	186	0
K011202	MSI BIPOLAR SHEATH	Medical Scientific, Inc.	2001-12-31	256	0
K012839	AUROPAL, ORDER-NO.: 2101	Wieland Edelmetalle GmbH & Co.	2001-12-31	130	0
K013942	POWDER FREE BLUE LATEX EXAMINATION GLOVE, NON-STERILE (PROTE	Wrp Specialty Products Sdn. Bhd.	2001-12-31	32	0
K013721	SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER	CIVCO Medical Instruments Co., Inc.	2001-12-28	49	3
K013586	MAGNETOM TRIO SYSTEM	Siemens Medical Systems, Inc.	2001-12-28	59	4
K012183	BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY	Bayer Diagnostics Corp.	2001-12-27	168	0
K011691	KIMSTIM AURICULAR ELECTRODE	Kim Institute For Rehabilitation Medicine, P.C.	2001-12-27	210	0
K014076	MODIFICATION TO TSRH SPINAL SYSTEM	Medtronic Sofamor Danek, Inc.	2001-12-27	16	0
K013991	PROLONG HIGHLY CROSSLINKED POLYETHTYLENE CRUCIATE RETAINING	Zimmer, Inc.	2001-12-27	23	0
K013289	BIOTEQUE VAGINAL PESSARIES	Bioteque America, Inc.	2001-12-27	86	0
K013563	LONG TROCHANTERIC NAIL SYSTEM	DePuy Orthopaedics, Inc.	2001-12-27	62	54
K011887	AVALON CUP SYSTEM	Orthopedic Source, Inc.	2001-12-27	192	0
K013915	D902 PH.I.S.I.O OXYGENATOR; D920 PH.I.S.I.O RESERVOIR; DIDEC	Dideco S.P.A.	2001-12-27	30	0
K013678	VICTORCH MEDITEK'S HCG TEST CARD	Victorch Meditek, Inc.	2001-12-27	50	0
K011939	FOTONA DUALIS, FOTONA DUALIS PLUS	Fotona D.D.	2001-12-27	189	0
K013702	VICTORCH HCG TEST STRIP	Victorch Meditek, Inc.	2001-12-27	49	0
K011406	SPINAL MESH SYSTEM	Medtronic Sofamor Danek, Inc.	2001-12-27	233	0
K013649	SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS	Sauflon Pharmaceuticals, Ltd.	2001-12-26	51	0
K013225	INSTACLOT FOR OTC USE, TRAUMASSTAT FOR PRESCRIPTION USE	Medafor, Inc.	2001-12-26	90	0
K013445	OSPREY SPHERICAL AND TORIC MULTIFOCAL SOFT CONTACT LENSES	Florida Optical Engineering, Inc.	2001-12-26	70	0
K011589	CORLINK AAD (3.5 TO 6.0 M M OUTER DIAMETER VESSELS),MODEL 20	Bypass , Ltd.	2001-12-26	217	0
K012731	SOLO-CARE PLUS MULTIPURPOSE SOLUTION	Ciba Vision Corporation	2001-12-26	133	0
K013591	XENF-TP RHINO-LARYNGOFIBERSCOPE, ITS ACESSORIES AND ANCILLAR	Olympus Optical Co., Ltd.	2001-12-26	57	0
K013549	SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971	Sigma Diagnostics, Inc.	2001-12-26	63	0
K013482	ABUSCREEN ONLINE OPIATES 300 / 2000	Roche Diagnostics Corp.	2001-12-21	63	0
K012569	MODIFICATION TO: INJECTABLE MIMIX	Biomet, Inc.	2001-12-21	134	0
K011889	ULTRA -THIN SDS BALLOON DILATATION CATHETER	Boston Scientific Corp	2001-12-21	186	0
K013817	GLO-SPEC	Sol Weiss MD, Inc.	2001-12-21	35	0
K013800	INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AU	Becton Dickinson Infusion Therapy Systems, Inc.	2001-12-21	36	0
K013995	MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TL	Medical Analysis Systems, Inc.	2001-12-21	17	0
K013527	MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RI	Synthes (Usa)	2001-12-21	59	1
K011832	VANGUARD REPROCESSED FEMORAL COMPRESSION DEVICE	Vanguard Medical Concepts, Inc.	2001-12-21	192	1
K013628	DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM	Diamedix Corp.	2001-12-21	46	0
K013436	NORMATEC PCD	Normatec, Inc.	2001-12-21	66	0
K013606	ACS 180 HOMOCYSTEINE ASSAY	Bayer Diagnostics Corp.	2001-12-21	51	0
K013850	STANDARD A, STANDARD B, STANDARD C, CAL, SLOPE	Diamond Diagnostics, Inc.	2001-12-21	31	0
K013193	MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE	Biolitec, Inc.	2001-12-21	88	0
K013371	UBIT-IR300 INFRARED SPECTROMETRY SYSTEM	Otsuka Pharmaceutical Co., Ltd.	2001-12-21	71	1
K013900	VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS	Ortho-Clinical Diagnostics	2001-12-21	28	0
K013466	SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343	Helena Laboratories	2001-12-21	64	0
K012514	DIGIPAN / DPI	Trophy Radiologie	2001-12-21	137	0
K013056	GELCLAIR CONCENTRATED ORAL GEL	Sinclair Pharmaceuticals, Ltd.	2001-12-21	101	0
K014099	BIOSCANNER PLUS	Polymer Technology Systems, Inc.	2001-12-21	8	0
K013652	WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002	Wiener Laboratories Saic	2001-12-21	45	0
K011960	LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS POCK	Lares Research, Inc.	2001-12-21	182	0
K013698	AST (SGOT)	Jas Diagnostics, Inc.	2001-12-21	44	0
K011702	VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS C	Vertis Neuroscience, Inc.	2001-12-21	203	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