510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.

Show the numbers

510(k) clearances by decision year, the last 15 years of ingested records
Year	Clearances
2012	3,135
2013	3,052
2014	3,202
2015	3,020
2016	2,956
2017	3,200
2018	3,062
2019	2,918
2020	2,923
2021	3,023
2022	3,209
2023	3,346
2024	3,129
2025	3,225
2026	2,732

176,529 records, page 1399 of 3531

510(k) clearances, page 1399 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K032447	Cannulated Nugen Fx Screw Fully Threaded, Cannulated Nugen Fx Screw Partially Threaded	Linvatec Biomaterials, Ltd.	HWC	Class II	2004-04-16
K040872	Variant II Hemoglobin A1c	Bio-Rad Laboratories Inc.	LCP	Class II	2004-04-15
K040814	Modification to Precision Xtra Advanced Diabetes Management System	Abbott Medical	NBW	Class II	2004-04-15
K040528	Amluck Ya Horng Pc Compatible Wrist Blood Pressure Monitor, Model Ak-4000T	Ya Horng Electronic Co., Ltd.	DXN	Class II	2004-04-15
K040215	Vision-Sciences Cst-2000 Flexible Cystoscope with Slide-on Endosheath System	Cogentix Medical, Inc.	FAJ	Class II	2004-04-15
K040186	Anspach MRI Safe Surgical Drill System	The Anspach Effort, Inc.	HBB	Class II	2004-04-15
K040094	Piggyback Irrigating System	Kosin Technologies, LLC	LJH	Class II	2004-04-15
K033963	Ep Deflectable Catheters	Abbott Medical	DRF	Class II	2004-04-15
K033183	Reclear Phototherapy System, Model Fgcm0012	Curelight, Ltd.	GEX	Class II	2004-04-15
K023916	Bmr Neurotech Back TENS and Lumbar Support Device. Type 294	Bio-Medical Research, Ltd.	GZJ	Class II	2004-04-15
K040840	Teratech Model 10V5 Smart Probe	Teratech Corp.	ITX	Class II	2004-04-14
K040793	Felcare Powder Free, Polymer Coated Latex Examination Gloves	Hl Rubber Products Sdn Bhd	LYY	Class I	2004-04-14
K040787	Modification to Surgical Mesh Polymeric	Boston Scientific Corporation	OTN	Class II	2004-04-14
K040621	Acell Ubm Surgical Mesh	Acell, Inc.	FTM	Class II	2004-04-14
K040444	Ge Signa 3.0T with Excite Mr System	General Electric Co.	LNH	Class II	2004-04-14
K040415	Peri-Strips Staple Line Reinforcement - Sleeve and Strip Configurations - and Peri-Strips Dry Staple Line Reinforcement	SYNOVIS LIFE TECHNOLOGIES, Inc. (A Subsidiary of Baxter International Inc.)	DXZ	Class II	2004-04-14
K040331	Smith and Nephew Titanium Interference Screws	Smith & Nephew, Inc.	HWC	Class II	2004-04-14
K040188	Infinity Gammaxl and Sc 6802Xl with the Scio Gas Module	Draeger Medical Systems, Inc.	NHP	Class II	2004-04-14
K040169	Synthes Mandible External Fixator	Synthes (USA) Products LLC	MQN	Class II	2004-04-14
K040122	Mayo Clinic Bc-10 3.0T	Mayo Clinic	MOS	Class II	2004-04-14
K033961	Altius Oct System	Interpore Cross Intl.	KWP	Class II	2004-04-14
K033186	King Lt-D Disposable Oropharyngeal Airway, Models Klt 203, Klt 204 and Klt 205	King Systems Corporation.	CAE	Class I	2004-04-14
K031557	Cardiovit at-102	Schiller, AG	DPS	Class II	2004-04-14
K040668	E-Z Scan Ab5500+	Sonomed, Inc.	IYO	Class II	2004-04-13
K040342	Interlocking Detachable Coil System (Idc)	Boston Scientific Corporation	KRD	Class II	2004-04-13
K040004	Orthocord Suture	DePuy Mitek, Inc.	NEW	Class II	2004-04-13
K033710	Mr850 Respiratory Humidifier, Model Mr850jhu	Fisher & Paykel Healthcare, Inc.	BTT	Class II	2004-04-13
K033133	Telecare D.r. Server Software System	Healthcare Vision, Inc.	MWI	Class II	2004-04-13
K040765	Synthes 5.0/7.3 Mm Cannulated Locking Screws	Synthes (USA) Products LLC	JDW	Class II	2004-04-12
K040762	Synthes (USA) Tibial Nail System Ex	Synthes (USA) Products LLC	JDS	Class II	2004-04-12
K040593	Periarticular Locking Plates and Screws, 2358, 2359 Series	Zimmer GmbH	HRS	Class II	2004-04-12
K040401	Lanx Anterior Cervial Plate System	Lanx, LLC	KWQ	Class II	2004-04-12
K040363	Ceramic Tipped Skull Pin	The Jerome Group, Inc.	LYT	Class II	2004-04-12
K040336	Synthes (USA) Lateral Entry Femoral Nail System	Synthes (USA) Products LLC	HSB	Class II	2004-04-12
K040330	Quiescence	Spectral Visualization & Development, Inc.	KLW	Class II	2004-04-12
K040285	Vectra Transportable Combo and Stim (Specialty Line Dealers); Intelect Transportable Combo and Stim (General Line Dealer	Chattanooga Group, Inc.	IMG	Class II	2004-04-12
K040158	Mfcd 2320	Barco N.V.	LLZ	Class II	2004-04-12
K033972	Scorpio Total Knee System	Howmedica Osteonics Corp	MBH	Class II	2004-04-12
K033546	Nuvasive Spinal System	NuVasive Inc	MNH	Class II	2004-04-12
K033290	Talon Infusion Set, Model Ip Xxxx	Abbott Medical	FPA	Class II	2004-04-12
K033148	Art Anterior Spinal System	Advanced Medical Technologies AG	KWQ	Class II	2004-04-12
K033116	Opti-Rider Deluxe	Hansung Econet Co., Ltd.	INI	Class II	2004-04-12
K032848	Medsafe System Inserter	Medsolve Technologies, LLC	KZH	Class II	2004-04-12
K031310	Tai Sheng Various Neox Powered Muscle Stimulator	Tai Sheng Electrical Machinery Co., Ltd.	IPF	Class II	2004-04-12
K040773	Pelvis Bellyboard Plus Patient Positioning System	Bionix Development Corp.	IYE	Class II	2004-04-09
K040714	Hybrid Endopore Endosseous Dental Implant	Innova Corp.	DZE	Class II	2004-04-09
K040599	Parkell Resin Glaze	Parkell, Inc.	EBD	Class II	2004-04-09
K040256	Pedi-Padz Radiolucent Multi-Function Pediatric Electrodes, Model 8900-1005	ZOLL Medical Corporation	MKJ	Class III	2004-04-09
K040056	Bio-Detek Electrode Adapter, Model R2001-90	ZOLL Medical Corporation	MKJ	Class III	2004-04-09
K040052	Fine Surgical Circumcision Clamp	Fine Surgical Instrument Corp.	HFX	Class II	2004-04-09