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 2026-11-02, 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 1038 of 3531

510(k) clearances, page 1038 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K093496	Non-Sterile, Powder-Free, Pink Latex Examination Gloves with And/or without Strawberry Scent and with Protein Content	Oon Corp. Resources	LYY	Class I	2010-02-03
K092746	Micronjet 600	Nanopass Technologies Ltd.	FMI	Class II	2010-02-03
K092491	Medefil's Heparin i.v. Flush Syringe 1 Unit/ml; 10 Units/ml; and 100 Units/ml in Various Fill Sizes	Medefil, Inc.	NZW	Class II	2010-02-03
K083764	Amphetamines II	Roche Diagnostics GmbH	DKZ	Class II	2010-02-03
K082230	Vectra Plus Laser System and Accessories	Xintec Corporation	GEX	Class II	2010-02-03
K100146	Evolve Eps Ortholoc	Wrightmedicaltechnologyinc	HRS	Class II	2010-02-02
K100090	Implantable Clip	Genicon, Inc.	FZP	Class II	2010-02-02
K100063	Hyperform Occlusion Balloon Catheter, Hyperglide Occlusion Balloon Catheter, Hyperglide Occlusion Balloon Catheter Model	Ev3, Inc.	MJN	Class II	2010-02-02
K093474	Depuy Fracture and Fusion Plating System	Depuy Orthopaedics Inc.	HRS	Class II	2010-02-02
K092970	General Patient Monitors, Models: G3c/ G3d/ G3f/ G3g/ G3h	General Meditech, Inc.	MHX	Class II	2010-02-02
K092774	Atlas Intervertebral Body Cage	Spinal Edge, LLC	MAX	Class II	2010-02-02
K093727	Powder Free Vinyl Patient Examination Gloves, Light Yello Color	Zibo Bolin Gloves Co., Ltd.	LYZ	Class I	2010-02-01
K093563	Iu22 Ultrasound System and Transducers	Philips North America LLC	IYN	Class II	2010-02-01
K093310	Gem Flow Coupler Device and System	SYNOVIS MICRO COMPANIES ALLIANCE, Inc. (a subsidiary of Baxter International Inc.)	MVR	Class II	2010-02-01
K093284	1.0T 8-Channel Panorama Breast Array Coil	Invivo Corporation	MOS	Class II	2010-02-01
K093112	Digitex Suture Delivery System, Model 52025, Digitex Suture Cartridge (Size O), Model 52026, Digitex Suture Cartridge	MEDLINE INDUSTRIES, LP - Northfield	GAW	Class II	2010-02-01
K092897	Lap Loop	Medsys, S.A.	KNF	Class II	2010-02-01
K092821	Tissuebag, Models: A10 211, A10 212, Tbi 100, Tbi1011, Tbi1021	Agency for Medical Innovations Inc.	GCJ	Class II	2010-02-01
K090755	Quanta Lite Aps/pt Igg and Igm Elisa	Inova Diagnostics, Inc.	OPN	Class II	2010-02-01
K090111	Flexpen Needle	Novo Nordisk a/S	FMI	Class II	2010-02-01
K082315	Ec50 Micro+ Smokerlyzer	Bedfont Scientific Ltd.	CCJ	Class II	2010-02-01
K100117	Lt3000 Combo Stimulator, Lt3001 TENS Stimulatory, Lt3002 Ems Stimulator	Shenzhen Dongdixin Technology Co., Ltd.	IPF	Class II	2010-01-29
K100050	R & D Systems Xeret Hematology Control	R & D Systems, Inc.	JPK	Class II	2010-01-29
K100014	Fully Automatic Electronic Blood Pressure Monitor, Model Kd-557	Andon Health Co., Ltd	DXN	Class II	2010-01-29
K093416	Trilogy 200 Ventilator	Respironics, Inc.	CBK	Class II	2010-01-29
K092828	Statnet, Model 3100	Hydrodot, Inc.	GXY	Class II	2010-01-29
K090427	Ursa Angiographic Catheter	Curative Medical Technology, Inc.	DQO	Class II	2010-01-29
K100067	Model Viamo Ssa-640A, Version 2.0 Ultrasound System	Toshiba America Medical Systems, In.C	ITX	Class II	2010-01-28
K093822	Docking Station,teirstein Edge,angioassist Combination Device, Angioassist Family	Shepherd Scientific, Inc.	DQX	Class II	2010-01-28
K093667	Shoulder Speeder Coil	Quality Electrodynamics	MOS	Class II	2010-01-28
K093560	Upcera Zirconia Blanks	Shenyang Upcera Co., Ltd.	EIH	Class II	2010-01-28
K093433	Variax Elbow System Plate Line Extension	Howmedica Osteonics Corp	HRS	Class II	2010-01-28
K093386	Chromalume Turbo Light Source with Xtremebeam Fiber Optic Headlampfst Model Fst	Bfw, Inc.	FST	Class II	2010-01-28
K093331	Sr Phonares Nhc	Ivoclar Vivadent, Inc.	ELM	Class II	2010-01-28
K093143	Mission Breath Alcohol Detector	Acon Laboratories, Inc.	DJZ	Class I	2010-01-28
K093021	Atlantis Slit Lamp	Us Opthalmic, LLC	HJO	Class II	2010-01-28
K092589	Thermotex Platinum System	Eas Consulting Group, LLC	ILY	Class II	2010-01-28
K092508	Fast-Fix 360 Meniscal Repair System, Striaght, Curved, Reverse Curved,fast Fix 360 Ab Meniscal Repair System, Straight,	Smith & Nephew, Inc.	GAT	Class II	2010-01-28
K092176	Take 1 Advanced Rigid Tray	Sybron Dental Specialties, Inc.	ELW	Class II	2010-01-28
K091794	Care2 Medical Nebulizer, Model 101/102, 201/202	Steve Islava	CAF	Class II	2010-01-28
K091583	Medefil's Normal Saline i.v. Flush Syringe	Medefil, Inc.	NGT	Class II	2010-01-28
K091278	Valeo Spacer System	Amedica Corp.	MAX	Class II	2010-01-28
K093995	Ig 4 Image Guided System	Veran Medical Technologies, Inc.	JAK	Class II	2010-01-27
K093484	Premise Flowable Modified	Sybron Dental Specialties, Inc.	EBF	Class II	2010-01-27
K093368	Butterfly Toner Model Gym070	Global Marketing Partners dba Gymmax USA	NGX	Class II	2010-01-27
K093271	Extension Set (Standardbore Tubing), Extension Set (Minibore Tubing), IV Administration Set ( Standard	Victus, Inc.	FPA	Class II	2010-01-27
K093182	Set Gri-Fill 3.0	Laboratorios Grifols, S.A.	LHI	Class II	2010-01-27
K093125	Alphaxenon Light 180 W and 300 W	Gimmi GmbH	GCT	Class II	2010-01-27
K092846	Airvo Series Humidifiers	Fisher & Paykel Healthcare, Inc.	BTT	Class II	2010-01-27
K092540	C-Ps Peek Optima Cervical Interbody Spacer, L-Ps Peek Optima Lumbar Interbody Spacer	RSB Spine LLC.	ODP	Class II	2010-01-27