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 2026-10-29, 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 926 of 3530

510(k) clearances, page 926 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K102898	Bellota Sonohysterography Catheter with Cervical Cone, Bellota Sonohysterography Catheter without Cervical Cone	Panpac Medical Corporation	LKF	Class II	2011-12-15
K102456	Intraoral Belsensor Gold	Takara Belmont USA, Inc.	MUH	Class II	2011-12-15
K112683	Smi Cardiovascular Pach	Solimas Medical, Inc.	DXZ	Class II	2011-12-14
K112501	Venus Pearl Plt Refill A1	Kulzer GmbH	EBF	Class II	2011-12-14
K112402	Ultramaxo2 Oxygen Analyer	Maxtec, LLC	CCL	Class II	2011-12-14
K112382	Terumo Aspriation Catheter	Terumo Medical Corp.	QEZ	Class II	2011-12-14
K112316	4-Web Alif Spinal Truss System (Sts)	4-Web, Inc.	MAX	Class II	2011-12-14
K112203	Compass Global Pressure, Compass Thoracentesis, Paracentesis, Compartment Pressure, Epidural Assist, Arterial Assist	Mirador Biomedical, Inc.	DRS	Class II	2011-12-14
K112160	Tapered Screw-Vent X Implant	ZimVie US Corp LLC	DZE	Class II	2011-12-14
K112057	Kdl Syringes and Needle	Shanghai Kindly Enterprise Dev. Group Co.	FMF	Class II	2011-12-14
K111753	Hitachi Clinical Analyzer S Test Reagent Catridge for: Cholestrol, Hdl, Ldl, and Triglyceride	Canon Medical Diagnostics USA, Inc.	CHH	Class I	2011-12-14
K111738	Chocolate Pta Balloon Catheter (Over the Wire) Guide Wire (0.014 and 0.018)	Trireme Medical, Inc.	DQY	Class II	2011-12-14
K111313	Exsept Skin and Wound Cleanser with Antimicrobial Preservative	Alcavis Hdc, LLC	FQH	Class II	2011-12-14
K110392	Psm Lomas / Benefit Screws	Psm Medical Solutions	OAT	Class II	2011-12-14
K113412	Target Detachable Coil	Stryker Corp.	HCG	Class II	2011-12-13
K113348	Cougar System	Johnson & Johnson	MAX	Class II	2011-12-13
K113079	Synthes Hemostatic Bone Putty	Synthes (USA) Products, LLC/Norian Corporation	MTJ	Unclassified	2011-12-13
K113034	Ge Innova Solid State XRAY Imager Flurosopic X Ray System	GE Healthcare	IZI	Class II	2011-12-13
K112857	Interface Bone Void Filler	Biostructures, LLC	MQV	Class II	2011-12-13
K112672	Headless Compression Screw	Skeletal Dynamics, Inc	HWC	Class II	2011-12-13
K112480	View 1 Imaging	Karl Storz Endoscopy-America, Inc.	LLZ	Class II	2011-12-13
K111418	Staxx(r) Xd System	Spine Wave Inc	MQP	Class II	2011-12-13
K111168	Precision Skin Emulsion	Precision Dermatology Incorporated	FRO	Unclassified	2011-12-13
K110604	Vbb System	Synthes GmbH	NDN	Class II	2011-12-13
K103161	Omega Laboratories Hair Drug Screening Assay for Opiates	Omega Laboratories, Inc.	DJG	Class II	2011-12-13
K102909	Somnobrux Splints	Somnomed Inc.	MQC	Unclassified	2011-12-13
DEN100002	Infrascanner, Model 1000	Infrascan, Inc.	OPT	Class II	2011-12-13
K113465	Acculif Tl Cage	Coalign Innovations, Inc.	MAX	Class II	2011-12-12
K113339	Ortholoc 3Dsi Locking Screws	Wrightmedicaltechnologyinc	HRS	Class II	2011-12-12
K113181	Celltracks Analyer II	Veridex, LLC	NQI	Class II	2011-12-12
K113102	Oncentra Manual Low Dose Rate Treatment Planning	Nucletron BV	MUJ	Class II	2011-12-12
K112983	Spacer-S	Tecres SpA	HSD	Class II	2011-12-12
K112675	Arrow-Lok Digital System	Arrowhead Medical Device Technologies, LLC	HTY	Class II	2011-12-12
K112658	Osteospring Footjack Subtalar Implant System	Osteospring Medical, Inc.	HWC	Class II	2011-12-12
K112459	Synthes Zero-P	Synthes Spine Co.Lp	OVE	Class II	2011-12-12
K111995	Xingtm Spine System	Implanova Co., Ltd.	MNH	Class II	2011-12-12
K102425	Zeus Elisa Cardiolipin Igg/igm/iga Test System	Zeus Scientific LLC	MID	Class II	2011-12-12
K113500	Canady Vieira Hybrid Plasma Scalpel	US Medical Innovations, LLC	GEI	Class II	2011-12-09
K113325	Evolution Mp Adaptive Cs Insert	Wrightmedicaltechnologyinc	JWH	Class II	2011-12-09
K113303	Osleobridge Idsf Spacer Conector	Merete GmbH	HSB	Class II	2011-12-09
K113300	Atb Advance Pta Dilatation Catheter	Cook Inc.	LIT	Class II	2011-12-09
K113084	Renovis Cannulated Screw System	Renovis Surgical Technologies, LLC	HWC	Class II	2011-12-09
K112946	Activ Varnish	Pulpdent Corporation	LBH	Class II	2011-12-09
K112637	Netkonnect Remote Network Extension	Nihon Kohden Corp.	MHX	Class II	2011-12-09
K112513	Ebony Pta 0.014 Peripheral Dilatation Catheter	Natec Medical Ltd	LIT	Class II	2011-12-09
K112229	Sarn Centrifugal Pump	Terumo Cardiovascular Systems Corporation	KFM	Class II	2011-12-09
K112028	Si-Lok Sacroiliac Joint Fixation System	Globus Medical, Inc.	HWC	Class II	2011-12-09
K111830	Fully Automatic Electronic Blood Pressure Monitor Model Kd-7902Btj, Fully Automatic Electronic Blood Pressure Monitor Mo	Andon Health Co., Ltd	DXN	Class II	2011-12-09
K111826	Fully Automatic Electronic Blood Pressure Monitor	Andon Health Co., Ltd	DXN	Class II	2011-12-09
K111452	Presage St2 Assay	Critical Care Diagnostics, Inc. (dba Critical Diag	OYG	Class II	2011-12-09