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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2956 of 3529

510(k) clearances, page 2956 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K853024	Rhinotest Mp	Intertronic, Inc.	BXQ	Class II	1985-09-27
K852868	Wundershade	Harry J. Bosworth Co.	EBF	Class II	1985-09-27
K852691	Odonto Toothbrush	Action Hygiene Products, Inc.	EFW	Class I	1985-09-27
K852608	Spectra 400 Extended Surveillance & Alert System	GE Medical Systems Information Technologies, Inc.	HGM	Class II	1985-09-27
K852194	Model Mt-50 Digital Memory Fever & Basal Thermomet	Sharp Electronics Corp.	LHD	Unclassified	1985-09-27
K852114	Ars Enterprises Pre-Vacuum Steam Sterilizer 85000	Ars Enterprises, Inc.	FLE	Class II	1985-09-27
K852113	Ars Enterprises New/remfr'd Gp Steam Sterilizer 81	Ars Enterprises, Inc.	FLE	Class II	1985-09-27
K851902	Model U-1000 Ultrasonic Scanner	Fukuda Denshi USA, Inc.	HEM	Class II	1985-09-27
K851895	Polygel Ultrasound Gel	Parker Laboratories, Inc.	IYO	Class II	1985-09-27
K851739	Dunn Vessel Occluder-Sterile	Richard J. Turner Assoc.	DXC	Class II	1985-09-27
K851034	Novatherm	MedTech Products, Inc.	KXZ	Class III	1985-09-27
K853552	Sentry Flexible TENS	Sentry Medical Products, Inc.	GXY	Class II	1985-09-26
K853190	Superspiro	Cdx Corp.	BZM	Class II	1985-09-26
K852952	Trauma Stand	Xre Corp.	IYB	Class I	1985-09-26
K852742	Osteograf Ar Alveolar Ridge Hydroxylapatite 18-40	Coors Biomedical Co.	LYC	Class II	1985-09-26
K852627	Maxi-Neb	Ashai Co., Ltd.	CCQ	Class I	1985-09-26
K852528	Bone Density CT Phantom	Computerized Imaging Reference Systems, Inc.	IXG	Class I	1985-09-26
K850838	Clinicomp Rdms Radionuclide Dispensing Mgmt. Softw	Clinicomp, Inc.	KPT	Class II	1985-09-26
K843905	Trauma Care Evaluation	Quantitative	PLB	Class II	1985-09-26
K843676	Varicella/zoster Virus	Institute Virion, Ltd.	GQW	Class II	1985-09-26
K843673	Respiratory Syncytial Virus	Institute Virion, Ltd.	GQG	Class I	1985-09-26
K843667	Parainfluenza 3	Institute Virion, Ltd.	GQS	Class I	1985-09-26
K843665	Parainfluenza 1	Institute Virion, Ltd.	GQS	Class I	1985-09-26
K843662	Measles Virus Rubeola	Institute Virion, Ltd.	GRJ	Class I	1985-09-26
K843660	In Fluenza B Virus	Institute Virion, Ltd.	GNX	Class I	1985-09-26
K843659	Influenza A2 Virus	Institute Virion, Ltd.	GNX	Class I	1985-09-26
K843658	H. Simplex Virus	Institute Virion, Ltd.	GQN	Class II	1985-09-26
K843657	Cytomegalovirus	Institute Virion, Ltd.	GQH	Class II	1985-09-26
K843649	Adenovirus	Institute Virion, Ltd.	GOD	Class I	1985-09-26
K853734	Apollo Densitometer	Astral Medical Systems	JQT	Class I	1985-09-25
K853699	Easy Analyzer & Easy-Test Reagent	Diagnostic Systems	JJE	Class I	1985-09-25
K853539	Abbott Testpack Hcg(urine) Diagnostic Kit	Abbott Medical	JHI	Class II	1985-09-25
K853148	Hot or Heat Pack	Matrix Intl.	IMD	Class I	1985-09-25
K853100	Cobe Catheter W/guidewire Assembly Kit	Cobe Laboratories, Inc.	DYB	Class II	1985-09-25
K852914	Angiographic, Wedge Press, Dual Thermod & Infusion	Norton Performance Plastics Corp.	DQY	Class II	1985-09-25
K852900	Cverne Cad Detector	Cherne Industries, Inc.	DXG	Class II	1985-09-25
K852491	American Pharmaseal Triple Lumen Catheter	American Pharmaseal Div. Ahsc	DQY	Class II	1985-09-25
K852382	Cardiotomy/mediastinal Autotransfusion Reservoir	American Bentley	DTN	Class II	1985-09-25
K853678	Kambin Spinal Instrument Set	Pilling Co.	HTZ	Class I	1985-09-24
K853662	Mueller Curved Stem Hemi-Prosthesis	Protek, Inc.	KWL	Class II	1985-09-24
K853660	Micro Surgical Drill System	Acumed Instruments Corp.			1985-09-24
K853659	Powered Irrigation for Micro Surgical Drill	Acumed Instruments Corp.			1985-09-24
K853658	Burs for Micro Surgical Drill System	Acumed Instruments Corp.	GFF	Class I	1985-09-24
K853594	Vessa Flivva	Vessa, Ltd.	ITI	Class II	1985-09-24
K853593	Vessa Travvla	Vessa, Ltd.	ITI	Class II	1985-09-24
K853528	Stainless Steel & Carbon Steel Sterile Blades	Abco Dealers, Inc.	GES	Class I	1985-09-24
K853499	Micron-Scope	Magnum Diamond, Inc.	HNN	Class I	1985-09-24
K853359	Reliance 1379	Dentsply Intl.	HRJ	Class I	1985-09-24
K853189	Creat Brand I/a Pack Creat Brand Phaco Pack	Aesthetech Corp.	HQC	Class II	1985-09-24
K853186	Silastic Inflatable Bone Plug H.p.	Dow Corning Corp. Healthcare Industries Materials	LZN	Class II	1985-09-24