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 975 of 3531

510(k) clearances, page 975 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K103127	Somatom Definition as	Siemens Medical Solutions USA, Inc.	JAK	Class II	2011-03-04
K102642	Sonoscape Ultrasound System and Transducers Model Ssi-8000, 2P1 Phased Array, 5P1 Phased Array Model 2P1, 5P1, 6V1 Micro	Sonoscape Company Limited	IYN	Class II	2011-03-04
K102610	Focus EMG Device	Teleemg, LLC USA	IKN	Class II	2011-03-04
K102474	Flaatz 750E	DRTECH Corporation	MQB	Class II	2011-03-04
K102464	Quadrox-I Neonatal Microporous Membrane Oxygenator with Integrated Arterial Filter with Softline/bioline Coating	MAQUET CARDIOPULMONARY GmbH	DTZ	Class II	2011-03-04
K102320	Compressible Limb and Circulation Therapy System Model Lx7(v7)	Daesung Maref Co.,Ltd	IRP	Class II	2011-03-04
K102229	Pulmotrack 2020 System	Karmelsonix	BZM	Class II	2011-03-04
K093584	Ez-Mister	N.M. Beale Co., Inc.	CCT	Class II	2011-03-04
K092622	Sterrad 100Nx Sterilizer Express Cycle	Advanced Sterilization Products	MLR	Class II	2011-03-04
K110295	Interlock-35 Fibered Idc Occlusion System	Boston Scientific Corporation	KRD	Class II	2011-03-03
K103750	Nuvasive Traverse Plate System	NuVasive Inc	KWQ	Class II	2011-03-03
K103679	Axis Pacs, Hms Pacs	Axis Health Care, LLC	LLZ	Class II	2011-03-03
K103477	Permobil M300 / M400	Permobil, AB	ITI	Class II	2011-03-03
K103142	Spacelabs Multi-Parameter Module	GE Healthcare	DSI	Class II	2011-03-03
K103126	Trophon Chemical Indicator	Nanosonics Limited	JOJ	Class II	2011-03-03
K102912	Interlock Fibered Idc Occlusion System	Boston Scientific Corporation	KRD	Class II	2011-03-03
K102636	Zenith Pedicle System	Apollo Spine, Inc.	MNH	Class II	2011-03-03
K102580	Vanguard Removable Molded Poly Tibia	Biomet Manufacturing Corp	JWH	Class II	2011-03-03
K102554	Avita Scaneo Ir Thermometer Model Ts4x Series	Avita Corporation	FLL	Class II	2011-03-03
K102403	Sam Chest Seal with Vavle; Sam Chest Seal	Sam Medical Products	NAD	Class I	2011-03-03
K102019	Restoration Acetabular Wedge Augments	Howmedica Osteonics Corp	LPH	Class II	2011-03-03
K101820	Non-Sterile, Blue & White Powdered Nitrile Examination Gloves	Yty Industry (Manjung) Sdn. Bhd.	LZA	Class I	2011-03-03
K093830	Medline Angiographic Control Syringe	MEDLINE INDUSTRIES, LP - Northfield	DXT	Class II	2011-03-03
K110456	Pharmajet 0.1 Ml Intradermal Needle-Free Injection System	Pharmajet, Inc.	KZE	Class II	2011-03-02
K110065	Spaulding Iq Electrocardiograph	Spaulding Clinical Research, LLC	DPS	Class II	2011-03-02
K103748	Laguna Pedicle Screw System	Phygen, LLC	NKB	Class II	2011-03-02
K103741	Surgisure Tissue Removal System	Interlace Medical, Inc.	GCJ	Class II	2011-03-02
K103613	Inpectra Sto2 Spot Check	Hutchinson Technology, Inc.	MUD	Class II	2011-03-02
K103488	Concorde Bullet Cage System	Johnson & Johnson	MAX	Class II	2011-03-02
K103002	Synthes Multiloc Proximal Humeral Nailing System	Synthes (USA) Products LLC	HSB	Class II	2011-03-02
K102825	Blood Pressure Cuff	Apk Technology Co., Ltd	DXQ	Class II	2011-03-02
K101850	Spacelabs Bleasesirius Anesthesia Workstation	GE Healthcare	CBK	Class II	2011-03-02
K103647	Thd Disposable Anoscopes, Proctoscopes and Rectoscopes	Thd SpA	FER	Class II	2011-03-01
K103167	Stellar 150	Resmed Germany, Inc.	MNT	Class II	2011-03-01
K102172	Msa Hip System	Global Manufacturing Technology	MEH	Class II	2011-03-01
K101876	Digital Electrocardiograph, Models ECG-1210, ECG-1230, ECG-3010, ECG-6010	Shenzhen Biocare Electronics Co., Ltd.	DPS	Class II	2011-03-01
K101569	V-Trust Model Td-2202 Portable ECG Recorder	Taidoc Technology Corporation	DPS	Class II	2011-03-01
K092275	Randox Ecstasy (Mdma) Assay	Randox Laboratories, Limited	DKZ	Class II	2011-03-01
K091010	Trokamed Morcellator	Trokamed GmbH	HET	Class II	2011-03-01
K110362	Vanguard Asymmetrical Patellar Component	Biomet Manufacturing Corp	JWH	Class II	2011-02-28
K110047	Verticor K-Wire System	Verticor, Ltd.	HTY	Class II	2011-02-28
K103840	Curved / Straight / Mini / Hook Scissor Tip, Dissector Tip, Surgical Handle	Flexbar Machine Corp.	GEI	Class II	2011-02-28
K103660	Lanx Cervical Intervertebral Body Fusion System	Lanx, Inc.	ODP	Class II	2011-02-28
K103399	General Denistry Motor	Aseptico, Inc.	EKX	Class I	2011-02-28
K103120	Corin Biolox Delta Femoral Heads	Corin USA	LZO	Class II	2011-02-28
K102397	Kyphon Xpede Bone Cement	Medtronic, Inc.	NDN	Class II	2011-02-28
K110428	Escom 100	Spident Co., Ltd.	EBF	Class II	2011-02-25
K110241	Endologix Guidewire	Techdevice Corporation	DQX	Class II	2011-02-25
K110163	Approach Pro St Wire Guide	Cook Incorporated	DQX	Class II	2011-02-25
K110120	Echelon Rapid Cardiac Coil	FUJIFILM Healthcare Americas Corporation	MOS	Class II	2011-02-25