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 947 of 3531

510(k) clearances, page 947 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K102511	Meridan Filter System- Jungular/subeclavian Delivery Kit	C.R. Bard Inc	DTK	Class II	2011-08-24
K111741	Integra(tm) Cusa Nxt(tm) Bone Tips	Integra Burlington Ma, Inc. (Formerly Integra Radi	LFL	Unclassified	2011-08-23
K111620	Skeletal Dynamics Geminus Volar Distal Radius Plate Model Standard 3 Hole Right, Standard 3 Hole Left, Skeletal Dynamics	Skeletal Dynamics, Inc	HRS	Class II	2011-08-23
K111589	Powder Free Nitrile Patient Examination Glove with Colloidal Oatmeal Usp a Skin Protectant Drug	Derma Care Plus Products, LLC	LZA	Class I	2011-08-23
K111507	Cdc Human Influenza Virus Real-Time Rt-PCR Diagnostic Panel	Centers for Disease Control and Prevention	OQW	Class II	2011-08-23
K111502	Streamline Tl Spinal System	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	NKB	Class II	2011-08-23
K111373	Ct42 Cardiac Computed Tomography (CT) Software	Circle Cardiovascular Imaging Inc	LLZ	Class II	2011-08-23
K111207	Respire Blue Series	Respire Medical	LRK	Class II	2011-08-23
K111072	Bioplex 2200 Mmrv Igg It on Bioplex 2200 Multi-Analyte Detection System, Bioplex 2200 Mmrv Igg Calibrator Set, and Biopl	Bio-Rad Laboratories Inc.	OPL	Class II	2011-08-23
K110828	Ddrelement	SWISSRAY Medical, AG	KPR	Class II	2011-08-23
K110016	Powder Free Vinyl Patient Examination Gloves, Colored (Yellow)	Rongyao Plastic Produce Co., Ltd.	LYZ	Class I	2011-08-23
K102406	Pass Anterior Spinal System	Medicrea Technologies	KWQ	Class II	2011-08-23
K093915	Deka Tac Device	Deka Research & Development Corp.	FIG	Class II	2011-08-23
K111609	Boston Band	Boston Brace Intl., Inc.	MVA	Class II	2011-08-22
K111352	Talon Distalfix Proximal Femoral Nail	Orthopedic Designs North America, Inc.	HSB	Class II	2011-08-22
K111254	Relieva Solo Elite Sinus Balloon Catheter	Acclarent Inc	LRC	Class I	2011-08-22
K110584	Asahi Chikai Neurovascular Guide Wire	Asahi Intecc Co., Ltd.	MOF	Class II	2011-08-22
K110342	Yolo Curve	Yolo Medical, Inc.	ILY	Class II	2011-08-22
K112231	Lccs Insulated Spinal Needle (RF Cannula)	Lccs Products Limited	GXI	Class II	2011-08-19
K112124	Microcatheter	Boston Scientific Corporation	DQO	Class II	2011-08-19
K112108	Romeo Posterior Osteosynthesis System	Spineart SA	MNI	Class II	2011-08-19
K111957	Polaris Spinal System	Biomet Spine (Ebi, LLC)	NKB	Class II	2011-08-19
K111952	Access Folate Calibrators on the Access Immunoassay Systems Model A98033	Siemens Healthcare Diagnostics Inc.	JIT	Class II	2011-08-19
K111799	Nugait(tm) Subtalar Implant System	Ascension Orthopedic	HWC	Class II	2011-08-19
K111699	Profemur(r) Z Titanium Plasma Sprayed Hip Stem	Wrightmedicaltechnologyinc	KWA	Class III	2011-08-19
K111698	Profemur(r) E Cementless Hip Stem	Wrightmedicaltechnologyinc	KWA	Class III	2011-08-19
K111668	Cavios Cavity Liner	Neodental Chemical Products Co., Ltd.	EJK	Class II	2011-08-19
K111661	Arthrex Scapholunate Anchor	Arthrex GmbH	MBI	Class II	2011-08-19
K111628	P200t	Optos PLC.	MYC	Class II	2011-08-19
K111616	E-Cube	Saeshin Precision Co., Ltd.	EKX	Class I	2011-08-19
K111550	Sonoma Fastrac Clavicle Fracture Repair Device Model Sonoma Fastrac Xxyyy(x=dia, Yyy=length- in Mm)	Sonoma Orthopedic Products, Inc.	HSB	Class II	2011-08-19
K111508	Trident Specimen Radiography System, Model : Rc Tri-00001	Hologic, Inc.	MWP	Class II	2011-08-19
K111441	Unimax Veress Needle	Unimax Medical Systems Inc.	HIF	Class II	2011-08-19
K111432	Evolve (R) Triad (Tm) Plating System and Evolve (R) Triad (Tm) Bone Screws	Wrightmedicaltechnologyinc	HRS	Class II	2011-08-19
K111365	Vitala Continence Control Device	ConvaTec Limited	EZQ	Class I	2011-08-19
K110879	Biomet Sports Medicine Juggerknot (Tm) Mini Soft Anchor	Biomet Sports Medicine	MBI	Class II	2011-08-19
K110795	V200 Intelli-Trak Option	Respironics, Inc.	CBK	Class II	2011-08-19
K110757	Tl-Cermide Skin Barrier Emulsion	Trigen Laboratories, Inc.	FRO	Unclassified	2011-08-19
K110689	Inbody	Biospace Inc.	MNW	Class II	2011-08-19
K110316	Infosend Gsm	Fisher & Paykel Healthcare, Inc.	BZD	Class II	2011-08-19
K110301	Silk'n Fx	Home Skinovations, Ltd.	OHS	Class II	2011-08-19
K110172	Sonafine Wound Dressing	Stratus Pharmaceutical	FRO	Unclassified	2011-08-19
K103734	Powder Free Nitrile Examination Gloves White Colored Non-Sterile	Central Medicare Sdn Bhd	LZA	Class I	2011-08-19
K103027	Electrotorque Tlc	Kaltenbach & Voigt GmbH	EBW	Class I	2011-08-19
K102831	Rsi 4200	Reimers Systems, Inc.	CBF	Class II	2011-08-19
K102785	Trimed Radiocarpal Fusion System	Trimed Inc	HRS	Class II	2011-08-19
K102706	Ckmb Udr Assay	Sentinel CH SpA	JHS	Class II	2011-08-19
K102315	Staxx Xdl System	Spine Wave Inc	MQP	Class II	2011-08-19
K100874	Liposonix System, Model 1 P00xxxx	Medicis Technologies Corporation	OHV	Class II	2011-08-19
K112020	Syngo.ct Vascular Analysis	Siemens Medi Cal Solutions, Inc.	JAK	Class II	2011-08-18