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

2014 — Predicate Candidate Screening

3,202 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.

121 daysmedian FDA review time

305 days90th percentile

2,000clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K142124	AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM	Aseptico, Inc.	2014-12-31	149	0
K142289	PK Spatula	Gyrus Acmi, Inc.	2014-12-31	135	0
K142611	TYRX Neuro Absorbable Antibacterial Envelope	Medtronic Tyrx, Inc.	2014-12-31	106	0
K142699	LITe Plate System	Stryker Corporation	2014-12-31	100	0
K143175	AEx Generator; PlasmaBlade T	Medtronic Advanced Energy	2014-12-31	57	0
K133333	UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT, UNI	Blue Ocean Medical Product, LLC	2014-12-31	428	0
K141586	OWL CANNULAE	Diros Technology, Inc.	2014-12-30	200	0
K143188	3.Omm Biomet Cannulated Screw System	Biomet Manufacturing Corp	2014-12-30	55	1
K141868	TRIA FANP	Tria Beauty, Inc.	2014-12-30	173	0
K142173	NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE	Ecolab, Inc.	2014-12-30	145	0
K141695	ACROSSPINE PEDICLE SCREW SYSTEM	Arthro-Dif	2014-12-30	189	0
K141936	MICROBLAB, MICROLOOP	Carefusion Germany 234 GmbH	2014-12-29	165	0
K142746	G7 Finned Acetabular Shell	Biomet Manufactuting Corp.	2014-12-29	96	0
K143378	AQUARIUS Gastrostomy Replacement Tube	Degania Silicone , Ltd.	2014-12-29	34	0
K140649	VECTRIX EXTERNAL FIXATOR	3D Medical Concepts, LLC	2014-12-29	291	0
K141878	HONGYUN POWDER-FREE YELLOW VINYL PATIENT EXAMINATION GLOVES	Tangshan Hongyun Plastic Products Co., Ltd.	2014-12-24	166	0
K142407	Straight Stud Attachment	Sterngold Dental, LLC	2014-12-24	118	0
K141046	MIDI-SRS	Srmc Co., Ltd.	2014-12-24	245	0
K142429	CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delive	Codman & Shurtleff, Inc.	2014-12-24	117	0
K143352	IMMULITE 2000 Ferritin Calibration Verification Material, IM	Siemens Healthcare Diagnostics, Inc.	2014-12-24	30	0
K140387	Burn Resuscitation Decision Support System - Clinical (BRDSS	The Surgeon General, Department of the Army	2014-12-23	312	0
K142151	SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES	Thermo Fisher Scientific	2014-12-23	139	0
K142933	Biomet Tibial trays	Biomet, Inc.	2014-12-23	75	2
K142326	HP Tissue Matrix	Lifecell Corporation	2014-12-23	125	0
K141920	Wrist Hemiarthroplasty System	Arthrosurface, Inc.	2014-12-23	160	0
K142328	nvc	Nvision Biomedical Technologies, LLC	2014-12-23	125	0
K142502	ALIANS ULNA LOCKING PLATING SYSTEM	Newclip Technics	2014-12-23	109	0
K142564	JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MIN	JMS North America Corporation	2014-12-23	103	0
K143407	Klassic HD Hip System	Total Joint Othopedics, Inc.	2014-12-23	25	0
K141479	KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS	Covidien	2014-12-23	202	0
K140436	ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIB	Fujirebio Diagnostics,Inc.	2014-12-23	305	0
K142630	Instru-Safe Instrument Protection System	Summit Medical, Inc.	2014-12-23	97	0
K142697	NExCT 7	Neurologica Corporation	2014-12-23	92	0
K143197	Nice1	Nice Recovery Systems, LLC	2014-12-23	47	0
K142427	TISSUE CONTAINMENT SYSTEM; 10, 14, 17, 25	Applied Medical Resources	2014-12-23	116	0
K143376	ADIVA Centaur Progesterone Master Curve Material (MCM), ADIV	Siemens Healthcare Diagnostics, Inc.	2014-12-23	28	0
K142373	Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno	Beckman Coulter, Inc.	2014-12-22	119	0
K142682	The Lipogems System	Lipogems International Spa	2014-12-22	94	0
K143195	Passport Series Patient Monitors (including Passport 17M, Pa	Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.	2014-12-22	46	0
K143067	Carnation Ambulatory Monitor	Bardy Diagnostics, Inc.	2014-12-22	59	0
K143429	Passage Hemostasis Valve	Merit Medical Systems, Inc.	2014-12-22	21	0
K141721	BOVINE PERICARDIUM PATCH	Collafirm, LLC	2014-12-22	180	0
K142558	Caspian OCT/MESA Mini/DENALI Mini Spinal System	K2m	2014-12-22	102	0
K142391	Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagen	ACON Laboratories, Inc.	2014-12-22	117	0
K142787	Zimmer Persona Personalized Knee System	Zimmer, Inc.	2014-12-22	87	0
K142528	AnthroBridge-Screw 25,30,35,40,45,50mm; AnthroBridge- Proxim	Agent Medical, LLC	2014-12-22	104	0
K143069	HEMASORBPLUS press Resorable Hemostatic Bone Putty	Orthocon, Inc.	2014-12-22	56	0
K143138	AxSOS 3 Ti Locking Plate System	Stryker Trauma AG	2014-12-22	49	0
K140989	POWDER FREE NITRILE SURGICAL GLOVES, WHITE COLOR (BRAND NAME	Hebei Hongsen Plastics Technology Co, Ltd.	2014-12-22	249	0
K142771	Xuanye Powder Free Vinyl Patient Examination Gloves, Clear (	Xuanhua Metallurgical Industry Co., Ltd.	2014-12-22	88	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