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 1758 of 3531

510(k) clearances, page 1758 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K980688	Integriti Patient Monitor	Alliance Instruments	MWI	Class II	1999-03-16
K990805	Modification to 7F Hydrolyser Thrombectomy Catheter	Cordis US Corp.	QEZ	Class II	1999-03-15
K990765	Flexfinder Guide Wire(regular Shaft/stiff Shaft) Marked Ink Bands, Flexfinder Guide Wire (Regular Shaft/stiff Shaft) No	Flexmedics	OCY	Class II	1999-03-15
K990606	Tetrafilcon a	CooperVision, Inc.	LPL	Class II	1999-03-15
K990598	Osteonics Solar Shoulder Humeral Bearing Head	Howmedica Osteonics Corp	KWS	Class II	1999-03-15
K990463	Medline Excel Wheelchairs	Medline	IOR	Class I	1999-03-15
K990423	Philips Nicol Collimator Family	Philips North America LLC	IZW	Class II	1999-03-15
K990391	Abbott Lyophilized Assayed Chemistry Control 3 Model #4E39-01	Bio-Rad	JJY	Class I	1999-03-15
K990309	Plus Fracture Head Prosthesis	Plus Orthopedics	KWL	Class II	1999-03-15
K990152	Osteo Ic Retrograde/antegrade Femoral Nail Nut and Washer	Howmedica Osteonics Corp	HSB	Class II	1999-03-15
K990089	Silkam Nonabsorbable Silk Surgical Suture	Aesculap Inc	GAP	Class II	1999-03-15
K990019	Drg Medium Screw System	Dolphin Medical Technologies, Inc.	HWC	Class II	1999-03-15
K984583	The Bioplate Shunt Connector	Biomedics	JXG	Class II	1999-03-15
K984534	Preclude Acuseal Dura Substitute	W. L. Gore & Associates, Inc.	GXQ	Class II	1999-03-15
K984492	Tigran Hip Prosthesis	Ponmed, Ltd.	LPH	Class II	1999-03-15
K984427	Excelsior Porcelain System	Ney Dental, Inc.	EIH	Class II	1999-03-15
K984190	Back-on-Trac, Model 101Bot	Back-On-Track, Inc.	HST	Class I	1999-03-15
K984018	Hemosleeve, Model 4.0Mm, 5.5Mm	Surgical Laser Technologies, Inc.	GEI	Class II	1999-03-15
K983882	Micro Endoscope-Stainless Steel, Model Mmd-1300, Micro Endoscope-Polyimide,model Mmd-1400	Micro Medical Devices, Inc.	HXR	Class I	1999-03-15
K983835	Implex Continuum Patella-Revision Hedrocel Patella	Implex Corp.	JWH	Class II	1999-03-15
K983742	Iti Dental Implant System	Straumann USA, LLC	DZE	Class II	1999-03-15
K983385	Hutchison Inflatable Silicone Tissue Expanders	Hutchison Intl., Inc.	LCJ	Unclassified	1999-03-15
K983295	Braun Thermoscan Irt3020/3500 One Secons Ear Thermometer, Model Irt3020/3520	Braun AG	FLL	Class II	1999-03-15
K983228	Bionicare Stimilator System, Model Bio-1000	Murray Electronics	NYN	Class II	1999-03-15
K983202	Harwill Medical Cervitula Cervical Spatula	Harwill Medical (Pty), Ltd.	HHT	Class II	1999-03-15
K983119	Entero-Test Hp, Model #102-01	Hdc Corp.	LIO	Class I	1999-03-15
K981955	Maxima, Trustex, Ria and Premium El Les Condoms	Ls Rubber Sdn Bhd	LTZ	Class II	1999-03-15
K980840	Lokki Dt	Hillard W. Welch	GEX	Class II	1999-03-15
K990531	Vitros Immunodiagnostic Products Oncology Controls	Ortho-Clinical Diagnostics, Inc.	JJY	Class I	1999-03-12
K990430	Ultracision Harmonic Scalpel Hand Piece	Ethicon Endo-Surgery Inc	LFL	Unclassified	1999-03-12
K990369	Synergy Cemented Hip Stem	Smith & Nephew, Inc.	JDI	Class II	1999-03-12
K990192	Biopsy-Digit	Sitco, Inc.	IZH	Class II	1999-03-12
K990049	Cd-Dent Digital Imaging Devices for Dental X-Ray Systems, Models 600, 1000 and 2000	Digident, Ltd.	MUH	Class II	1999-03-12
K984634	3D-Angio	Siemens Medical Corp.	JAK	Class II	1999-03-12
K984580	Biosaca System	Biosys AB (Publ)	OLV	Class II	1999-03-12
K984518	Sonic Innovations Completely-in-the-Canal Dsp Hearing Aid with Soft Shell	Sonic Innovations, Inc.	ESD	Class I	1999-03-12
K984289	Vitros Immunodiagnostic Products Psa Calibrators, Vitros Immunodiagnostic Products Psa Reagent Pack	Ortho-Clinical Diagnostics, Inc.	LTJ	Class II	1999-03-12
K983918	Radiolucent Cassette Limb Positioner (R-Clip)	Mastek, Inc.	IXA	Class II	1999-03-12
K983843	Bio-Button 6.5Mm, Bio-Button 8Mm, Model #'S Ar-2236B & Ar-2238B	Arthrex GmbH	MAI	Class II	1999-03-12
K983355	Sabratek Apm-2000 Ambulatory Patient Montor, Transcutaneous Temperature Monitor	Sabratek Corp.	FLL	Class II	1999-03-12
K982739	Gynex Electrodes	Gynex Corp.	HGI	Class II	1999-03-12
K982600	Profeel Synthetic Copolymer Surgical Gloves (Powdered)	Wembley Rubber Products (M) Sdn Bhd	KGO	Class I	1999-03-12
K982468	Immulite 2000 Thyroglobulin Model L2kty	Siemens Healthcare Diagnostics Inc.	MSW	Class II	1999-03-12
K982466	Immulite Thyroglobulin Model Lkty	Siemens Healthcare Diagnostics Inc.	MSW	Class II	1999-03-12
K980964	Maxima, Trustex, Ria and Premium Condoms	Ls Rubber Sdn Bhd	HIS	Class II	1999-03-12
K990573	Estech Arterial Remote Access Perfusion Cannula	Estech, Inc.	DXC	Class II	1999-03-11
K990506	Mabis Nb-02 Ultrasonic Nebulizer	Mabis Healthcare, Inc.	CAF	Class II	1999-03-11
K990240	Electroglottograph	Kay Elemetrics Corp.	KLX	Class II	1999-03-11
K984418	Universal Adjustable T-Rail Table Bracket	Medrad, Inc.	DXT	Class II	1999-03-11
K983927	Gt1 Floppy, Gt1 Hi-per Flex, Gt1 Light Support	Arterial Vascular Engineering, Inc.	DQT	Class II	1999-03-11