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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 755 of 3530

510(k) clearances, page 755 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K141248	Smart Segmentation Knowledge Based Contouring	Varian Medical Systems, Inc.	MUJ	Class II	2014-09-05
K140911	Unicel Dxh 800 Coulter Cellular Analysis System/ Unicel Dxh Slidemaker Stainer Coulter Cellular Analysis System	Siemens Healthcare Diagnostics Inc.	GKZ	Class II	2014-09-05
K140528	True Beam, True Beam Stx, Edge	Varian Medical Systems, Inc.	IYE	Class II	2014-09-05
K140280	Forticore	Nanovis, LLC	ODP	Class II	2014-09-05
K140013	Sopix Inside, Sopix2 Inside	Sopro - Acteon Group	MUH	Class II	2014-09-05
K134025	Aquilion One Vision Self-Propelled Scan Base Kit for Ivr-CT	Toshibamedical Systems Corporation	JAK	Class II	2014-09-05
K133895	Deka Smartxide Laser System	El.En S.p.A.	GEX	Class II	2014-09-05
K133739	Trusculpt	Cutera Inc	PBX	Class II	2014-09-05
K133324	Suresubtraction Lung	Toshiba Medical Systems Corporation, Japan	JAK	Class II	2014-09-05
K132245	Ajax Dental Unit	Pro Dental Services, LLC	EIA	Class I	2014-09-05
K131968	Longfian Oxygen Concentrator	Longfian Scitech Co., Ltd.	CAW	Class II	2014-09-05
DEN130031	Nephrocheck Test System	Astute Medical, Inc.	PIG	Class II	2014-09-05
K141950	Hfd100 Rocker Arm Accessory	Imris, Inc.	HBL	Class II	2014-09-04
K141831	Hydraview Guidewire	Brivant, Ltd.	DQX	Class II	2014-09-04
K141719	Biogel Pl Micro Surgical Glove	Molnlycke Health Care, US LLC	KGO	Class I	2014-09-04
K141673	Ivas 8 Gauge Bone Biopsy Kit	Stryker Corp.	KNW	Class II	2014-09-04
K141272	Floshield 10Mm Endoscopic Cannula and Blunt Obturator, Floshield 10Mm Endoscopic Cannula, Floshield 10Mm Blunt Obturator	Minimmally Invasive Devices	GCJ	Class II	2014-09-04
K140964	Calculase II	Karl Storz Endoscopy-America, Inc.	GEX	Class II	2014-09-04
K140947	Compat Enteral Delivery Pump Sets	Novartis Nutrition Corp.	PIF	Class II	2014-09-04
K140710	Biomet Graft Delivery Syringes	Biomet Spine (Aka Ebi, LLC)	FMF	Class II	2014-09-04
K134003	Rhinix Nasal Filter	Rhinix ApS	NUP	Class II	2014-09-04
K133889	Premium	Cousin Biotech SAS	FTL	Class II	2014-09-04
K133797	Qmaster-H/revo	Telesystems Co., Ltd.	OAS	Class II	2014-09-04
K141840	Trabecular Metal Tibial Cone Broach, Trabecular Metal Coupled Tibial Cone Broach	Zimmer GmbH	MBH	Class II	2014-09-03
K141635	Arthrex Ibalance Tka System	Arthrex GmbH	MBH	Class II	2014-09-03
K141590	EMG Blue Nitrile Medical Examination Glove Powder Free	Eco Medi Glove Sdn Bhd	LZA	Class I	2014-09-03
K141546	Vitalograph Model 7000 Spirotrac	Vitalograph Ireland Ltd.	BZG	Class II	2014-09-03
K141514	Synapse 3D Tensor Analysis	Fujifilm Meidcal Systems U.S.A.,Inc.	LLZ	Class II	2014-09-03
K141495	Truwave Disposable Pressure Transducer	Edwards Lifesciences LLC	DXO	Class II	2014-09-03
K141355	Volumetric Incentive Spirometer	Besmed Health Business Corporation	BWF	Class II	2014-09-03
K141293	Phot-X Iis Model 505	Takara Belmont Corporation	EHD	Class II	2014-09-03
K141144	Sta Liatest D-Di	Diagnostica Stago, Inc.	DAP	Class II	2014-09-03
K140877	Vericore Zirconia Blanks	Whip-Mix Corp.	EIH	Class II	2014-09-03
K140865	Infrared Heating Device	Pro Medical Supplies, Inc.	ILY	Class II	2014-09-03
K140804	Vdrive with V-Loop/ Vdrive Duo	Stereotaxis Inc	DXX	Class II	2014-09-03
K140786	Xenco Medical Cervical Interbody System	Xenco Medical LLC	ODP	Class II	2014-09-03
K140418	Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile	Wrp Rubber Products Sdn Bhd	LZA	Class I	2014-09-03
K134011	General Spinal System	Changzhou Dean Medical Instrument Co, Ltd.	MNH	Class II	2014-09-03
K133911	Genesys Spine Anterior Buttress Plate System	Genesys Spine	KWQ	Class II	2014-09-03
K133851	Alere Pbp2a Sa/cons Culture Colony Test	Alere Scarborough, Inc.	MYI	Class II	2014-09-03
K141370	Renovis Cemented Hip System	Renovis Surgical Technologies, LLC	JDI	Class II	2014-09-02
K141078	Orthofix Tl-Hex True Lok Hexalobe System (Tl-Hex)	Orthofix SRL	KTT	Class II	2014-09-02
K140874	Gh Disposable and Gh Reusable Blood Pressure Cuff	Shanghai Goahui Rubber and Plastic Company	DXQ	Class II	2014-09-02
K140690	Bs-480 Chemistry Analyzer, Bs-490 Chemistry Analyzer, Clc720i Chemistry Analyzer	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	CDQ	Class II	2014-09-02
K142221	MEMO 3D ReChord	Corcym Inc.	KRH	Class II	2014-08-29
K142097	Selec-3 I.v.administration Set	Biomedix Wai	FPA	Class II	2014-08-29
K141848	Iogyn System	Iogyn, Inc.	PGT	Class II	2014-08-29
K141796	Depuy Synthes Tomofix Osteotomy System	Synthes (USA) Products LLC	HRS	Class II	2014-08-29
K141440	Dicompacs Dx-R with Flat Panel	Oehm und Rehbein GmbH	MQB	Class II	2014-08-29
K141364	Climb Mammography Viewer Software	Climb Medical Systems, Inc.	LLZ	Class II	2014-08-29