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 2026-11-05, 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 1856 of 3531

510(k) clearances, page 1856 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K972351	Sendax Mdi (Mini Dental Implant)	Sendax Mdic Management, Inc.	DZE	Class II	1997-11-24
K972270	Nexgen Complete Knee Solution Convex Inset Patella Component	Zimmer GmbH	JWH	Class II	1997-11-24
K971999	Peripherally Inserted Central	B.Braun Medical, Inc.	LJS	Class II	1997-11-24
K971793	Very Private Intimate Moisture	Brandwynne Corp.	HIS	Class II	1997-11-24
K963933	Psn-120 Hollow Fiber Dialyzer and Psn-140 Hollow Fiber Dialyzer	Baxter Healthcare Corporation	FJI	Class II	1997-11-24
K974161	Stealthstation System	Surgical Navigation Technologies, Inc.	HAW	Class II	1997-11-21
K973889	Varian Multileaf Collimator with Dynamic Arc Therapy Feature	Varian Medical Systems, Inc.	IYE	Class II	1997-11-21
K973856	Giotto Ht	Sitco, Inc.	IZH	Class II	1997-11-21
K973815	High Risk Powdered Latex Examination Gloves (Blue Colour)	Sri Johani Sdn. Bhd.	LYY	Class I	1997-11-21
K973801	High Risk Powderfree Latex Examination Gloves (Blue Colour)	Sri Johani Sdn. Bhd.	LYY	Class I	1997-11-21
K973776	Reflections	CDB Corporation	DYW	Class II	1997-11-21
K973642	Orthopantomograph Op100 and Orthoceph Oc100	Instrumentarium Imaging, Inc.	EHD	Class II	1997-11-21
K973397	Syntac Sprint	Ivoclar North America, Inc.	EMA	Class II	1997-11-21
K973369	Roche Unimate Hdl Direct Reagen (with Pol Claim)	Roche Diagnostic Systems, Inc.	LBR	Class I	1997-11-21
K973356	K-Piston with Band Hook /Angular Piston	Heinz Kurz	ETB	Class II	1997-11-21
K973351	Elecsys Afp	Boehringer Mannheim Corp.	LOJ	Class II	1997-11-21
K973314	Spirosafe Filter	Micro Direct, Inc.	CAH	Class II	1997-11-21
K973232	Olympus Subfascial Endoscopic Perforating Vein Surgery (Seps) System, Its Associated Accessories and Ancillary Equipment	Olympus Winter & Ibe GmbH	GCJ	Class II	1997-11-21
K973193	Luxscope	Luxtec Corp.	HQF	Class II	1997-11-21
K973190	Accuprobe 450, Accuprobe 550/530 and the Accuprobe 600 Series	Cryomedical Sciences, Inc.	GEI	Class II	1997-11-21
K973184	Prostate Seeding Needle	Promex, Inc.	IWJ	Class I	1997-11-21
K973176	Seizure Emergency Equipment Kit; Seizure Kit	Lotus Technologies	KGA		1997-11-21
K973168	Smartview Options for Hispeed Ct/i	GE Healthcare	JAK	Class II	1997-11-21
K973166	Dow Corning Silastic Elastomer Q7-4750	Technical Products, Inc.	MIB	Class II	1997-11-21
K973163	Acetabular Shells with Mesh Ingrowth Surface	Howmedica Corp.	LPH	Class II	1997-11-21
K972582	Uresil Guidewire	Uresil, LLC	FGE	Class II	1997-11-21
K972450	Flextip Grasper	Endius, Inc.	EOB	Class II	1997-11-21
K971781	Greatbatch Scientific Mr Compatible Arthroscopes and Small Joint Arthroscopes	Wilson Greatbatch Technologies, Inc.	HRX	Class II	1997-11-21
K970326	Tritest Reagent Cd3 Fitc/cd8 Pe/cd45 Percp;with Trucount Absolute Count Tubes	Becton Dickinson Immunocytometry Systems	GKZ	Class II	1997-11-21
K970136	Digital Add-on Bucky	Swissray Teleray AG	KPR	Class II	1997-11-21
K965053	Tritest Reagent Cd3 Fitc/cd4 Pe/cd45 Percp; Trucount Absolute Count Tubes	Becton Dickinson Immunocytometry Systems	GKZ	Class II	1997-11-21
K974045	Venneto	Amsure Sports, Inc.	HQY	Class I	1997-11-20
K973813	Immunochemistry System Beta-2-Microglobulin Reagent	Beckman Instruments, Inc.	JZG	Class II	1997-11-20
K973673	Quickie Zippie Series, Quickie Breezy Series, Quick Folding Series, Quickie Rigid Series	Sunrise Medical, Inc.	IOR	Class I	1997-11-20
K973597	Al-47 (Isofilcon) Soft (Spherical) Daily Wear Contact Lens	Martin Dalsing	LPL	Class II	1997-11-20
K973529	Neuroline, Disposable Concentric Needle Electrodes	Medicotest, Inc.	IKT	Class II	1997-11-20
K973521	Variable Parallel Pin	Sulzer Calcitek, Inc.	DZE	Class II	1997-11-20
K973475	Carmeda Coated Cardiotherm Blood Cardioplegia Systems (Cbctxxx Series and Cbctxxxbr Series)	Medtronic, Inc.	DTR	Class II	1997-11-20
K973444	Teca Myoject Disposable Needle Electrodes	Medelec, Inc. D.B.A. Teca Corp.	IKT	Class II	1997-11-20
K973442	Teca Disposable Monopolar Needle Electrodes	Medelec, Inc. D.B.A. Teca Corp.	IKT	Class II	1997-11-20
K973321	Hoffmann II Compact Periarticular Clamp	Howmedica Corp.	KTT	Class II	1997-11-20
K973307	S-Rom Zirconia Ceramic Femoral Hip Head	Johnson & Johnson Professionals, Inc.	LZO	Class II	1997-11-20
K973276	Autodelfia Neonatal Htsh L Kit (B077-112)	Eg &G Wallac	JLW	Class II	1997-11-20
K973275	Kls-Martin Intraoral Distractor	KLS-Martin L.P.	MQN	Class II	1997-11-20
K973240	Synthes Proximal Femoral Nail(pfn) System Modification	Synthes (USA) Products LLC	HTY	Class II	1997-11-20
K973231	The Corifix Dynamic Hip Screw System	Corin USA	KTT	Class II	1997-11-20
K973192	Flexlens, Flexlens Toric	Specialty Ultravision, Inc.	LPL	Class II	1997-11-20
K973164	Howmedica Total Stabilizer Knee Components	Howmedica Corp.	JWH	Class II	1997-11-20
K973162	Dual Radiation Targeting System Drts Drape	Hogan & Hartson	IWE	Class I	1997-11-20
K973148	Macom	A.Stein - Regulatory Affairs Consulting	LLZ	Class II	1997-11-20