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 1092 of 3531

510(k) clearances, page 1092 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K090281	Accutech Family of Powerflex Laser Delivery Devices	Accutech Medical Technologies, Inc.	GEX	Class II	2009-03-04
K090252	Modification to: Lanx Spinal Fixation System	Lanx, Inc.	KWP	Class II	2009-03-04
K090248	BIPAP Autosv	Respironics Inc., Sleep & Home Respiratory Group	MNS	Class II	2009-03-04
K083791	Corflo Anti IV Enteral Feeding Set, Model: 20-1060Aiv-S	Halyard Health	FPD	Class II	2009-03-04
K083612	Aperfix Femoral Implant with Inserter, 9,10,11 Mm X 35Mm and X 29Mm	Cayenne Medical Inc.	HWC	Class II	2009-03-04
K083607	Aperfix Implant with Inserter, 8, 9, 10, 11, Mm X30 Mm	Cayenne Medical Inc.	HWC	Class II	2009-03-04
K083573	Synthes (USA) 3.5Mm Locking Attachment Plates	Synthes (USA) Products LLC	HRS	Class II	2009-03-04
K083451	Portex Epidural Filter, Model 100/386/010, Various Standard and Custom Trays	Abbott Medical	BSN	Class II	2009-03-04
K083357	Open Abdomen Negative Pressure Therapy System, Model 370502, Canister, Model 370510	KCI USA, Inc.	OMP	Class II	2009-03-04
K083311	Aesculap Cespace Peek Intervertebral Body Fusion System	Aesculap Inc	ODP	Class II	2009-03-04
K083192	Inclusive Titanium Abutment Blanks	Inclusive Dental Solutions	NHA	Class II	2009-03-04
K083182	Datacom Dc Pacs	Datacom Technology Corp.	LLZ	Class II	2009-03-04
K083122	Hospital Full Face Mask Non Vented, Model: Rt041	Fisher & Paykel Healthcare, Inc.	CBK	Class II	2009-03-04
K083081	Modification to Securacath, Model: Spk01	Interrad Medical Inc	OKC	Class II	2009-03-04
K083005	Nangel	Teknimed SAS	LYC	Class II	2009-03-04
K082487	M-50 Series Spo2 Sensor	Beijing Choice Electronic Technololgy Co., Ltd.	DQA	Class II	2009-03-04
K081984	Laborpro System	Trig Medical, Ltd.	NPB	Class II	2009-03-04
K080611	Mesa Spinal System	K2M, Inc	MNH	Class II	2009-03-04
K090274	Micrus One 2 One Guidewire and Soft Guidewire	Micrus Endovascular Corporation	DQX	Class II	2009-03-03
K083788	Endo Optiks Urological Catheter for Endoscopy, Model Sessr	Endooptiks, Inc.	EYB	Class II	2009-03-03
K083566	R3 Constrained Liner, Constrained Liner	Smith & Nephew, Inc.	KWZ	Class II	2009-03-03
K083511	Enviro Sharp Solutions 3	Industrial Water Solutions, Inc.	MMK	Class II	2009-03-03
K083471	Gmd Universal Sling, Model Product Code 1010 and 1020	Generic Medical Device, Inc.	OTN	Class II	2009-03-03
K083766	Phoglass Cem	S & C Polymer GmbH	EMA	Class II	2009-03-02
K083636	Reprocessed External Fixation Device	Sterilmed Inc	KTT	Class II	2009-03-02
K083596	Reekross Family or Otw Pta Catheters	Clearstream Technologies Ltd.	DQY	Class II	2009-03-02
K083456	Nihon Kohden CO2 Sensor Kit, Model Tg-970P	Nihon Kohden America Inc	CCK	Class II	2009-03-02
K083414	Radionics Xknife Hdrt System	Integra Radionics, Inc.	MUJ	Class II	2009-03-02
K083233	The Pft Filter	Pulmonary Filtration Technologies, LLC	BZG	Class II	2009-03-02
K082074	Atricure Cryo1 Cryo-Ablation Probe	AtriCure, Inc.	GEH	Class II	2009-03-02
K081851	Neoss Access Abutments	Neoss, Ltd.	NHA	Class II	2009-03-02
K090445	Atmos C361/c451 Suction Pump	Atmos, Inc.	BTA	Class II	2009-02-27
K090369	Prodrive Line of Dental Handpieces	Prodrive Systems, Inc.	EFB	Class I	2009-02-27
K090362	Imag, Ipod, Ez-Find and Islide	Voguestrap	LRX	Class II	2009-02-27
K090238	Sedecal X-Plus Lp Plus Digital Diagnostic X-Ray Systems	Sedecal S.A.	KPR	Class II	2009-02-27
K090046	Concerto Detachable Coil System	Medtronic, Inc.	KRD	Class II	2009-02-27
K083900	Erbium Fractional Handpiece	Palomar Medical Products, Inc.	GEX	Class II	2009-02-27
K083680	Vitros Chemistry Products K+dt Slides: Vitros Chemistry Products Dt Calibrator Kit, Model K+dt Slides: 153 2258	Ortho-Clinical Diagnostics, Inc.	CEM	Class II	2009-02-27
K083661	Avs Tl Peek Spacers	Stryker Corp.	MAX	Class II	2009-02-27
K083479	Biocryl X	Great Lakes Orthodontics, Ltd.	EBI	Class II	2009-02-27
K083465	Dimension Vista Creatine Kinase Flex Reagent Cartridge and Dimension Vista Creatine Kinase Mb Flex Reagent Cartridge	Siemens Healthcare Diagnostics Inc.	CGS	Class II	2009-02-27
K083462	Dimension Vista System Enzyme 5 Calibrator, Model Kc350	Siemens Healthcare Diagnostics Inc.	JIT	Class II	2009-02-27
K083395	Semi-Fully Automatic Electronic Blood Pressure Monitor, Models: Kd-322,Kd-622,Kd-575,Kd-525E,kd-593,Kd-595,Kd-596,Kd-598	Andon Health Co., Ltd	DXN	Class II	2009-02-27
K083179	Mediled Phototherapy Lamp	Medix I.C.S.A.	LBI	Class II	2009-02-27
K083124	Nim 3.0	Medtronic Xomed, Inc.	GWF	Class II	2009-02-27
K082850	Eye Spheres	Product & Educational Services	HPZ	Class II	2009-02-27
K082771	Protron Technologies, Llc Stethotron	Protron Technologies, LLC	DQD	Class II	2009-02-27
K082682	Surgisis Biodesign Enterocutaneous Fistula Plug	Cook Biotech, Inc.	FTM	Class II	2009-02-27
K082328	Glucodr Plus System, Model Agm-3000	All Medicus Co., Ltd.	NBW	Class II	2009-02-27
K081240	Tiger Discectomy Device	Spinal Devices, LLC	HRX	Class II	2009-02-27