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 2026-10-21, 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 2992 of 3529

510(k) clearances, page 2992 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K850642	Temp/sc 200T -Skin Conductance/skin Temp Biofeedba	Thought Technology Ltd.	HCC	Class II	1985-05-17
K850573	Curamed 402	Fluidotherapy Corp.	IMJ	Class II	1985-05-17
K844734	Alcide Ren New-D	Alcide Corp.	FKQ	Class II	1985-05-17
K844193	Quinton Injection Sealing Cap	Quinton, Inc.	FOZ	Class II	1985-05-17
K844118	Therapeutic Limb Manipulator	Donald E. Redding	BXB	Class I	1985-05-17
K851861	Programalith III Model 249 Pulse Generator	Pacesetter Systems	DXY	Class III	1985-05-16
K851853	Sterile Gowns, Masks & Towels	Biological & Environmental Control Laboratories			1985-05-16
K851699	Cook Pacemaker Corp. 332T Bipolar Cardiac Pulse Ge	Cook Pacemaker Corp.	DXY	Class III	1985-05-16
K851497	Marlin Contact Lens Case	Marlin Industries	HPX	Unclassified	1985-05-16
K851322	Personal C3 3-Channel Electrocardiograph	Parexel Intl. Corp.	DPS	Class II	1985-05-16
K851141	Teleflex Medical Introducer Catheter	Teleflexmedical, Inc.	DYB	Class II	1985-05-16
K851102	Vasoscreen Impedance Plethysmograph	Sonicaid, Inc.	DQB	Class II	1985-05-16
K851088	Umi Angiographic Catheter	Universal Medical Instrument Corp.	DQO	Class II	1985-05-16
K851049	Norelco Blood Pressure Meter	Philips Park	DXN	Class II	1985-05-16
K851035	American Bentley Oxygenator Max-2	American Bentley	DTZ	Class II	1985-05-16
K851004	Cardiotomy Reservoir Brs-Xxx & Holder Brs-Hxx	Gish Biomedical, Inc.	DTP	Class II	1985-05-16
K850893	Bp/clinic Sys Measurement, Bp Non-Invasive	Sun Dance Technology, Inc.	DXN	Class II	1985-05-16
K850876	Ligtvoet L80.2 Lightfoot L80.2 Power Wheelchair	Ketronic, Inc.	ITI	Class II	1985-05-16
K850875	Action-Wheels & Play Wheels	Ketronic, Inc.			1985-05-16
K850867	Accutracker Heart-Rate Monitor	Eutectic Electronics, Inc.	DXN	Class II	1985-05-16
K850695	Wsp Code 4301 Diomaster Therapeutic	Warne Surgical Products, Ltd.	FAP	Class II	1985-05-16
K850621	Gambro Plasmafiltration System	Gambro, Inc.	LKN	Unclassified	1985-05-16
K850323	Telemetry Software for G-2000 Electrocardiograph	Eaton Medical Group	DPS	Class II	1985-05-16
K850322	Resting ECG Software Fro G-2000 Electrocardiograph	Eaton Medical Group	DPS	Class II	1985-05-16
K850135	Medwatch 400 Cardiac Central Nurses Station	Medwatch Systems, Inc.	DRT	Class II	1985-05-16
K844972	Adv Cardio Sys Dbl Lumen Balloon Dilata Catheter	Advanced Cardiovascular Systems, Inc.	LIT	Class II	1985-05-16
K844840	Deseret Introducer Set	Parke-Davis Co.	DYB	Class II	1985-05-16
K844800	Opti-Flow & Opti-Torque Angiographic Catheters	Vas-Cath of Canada, Ltd.	DQO	Class II	1985-05-16
K844731	Kontron Supermon 7210 Patient Monitor	Kontron Instruments, Inc.	DRT	Class II	1985-05-16
K844356	System 930 Argon Photocoagulator	Coherent Medical Group	HQB	Class II	1985-05-16
K842435	Model T 101 Clinical Transmitter	Biometric Products, Inc.	DXH	Class II	1985-05-16
K840522	Recomed Blood-Flow Meter H236-052-02	Litton Medical Electronics	DPW	Class II	1985-05-16
K840445	Synkara	Lectec Corp.	DRX	Class II	1985-05-16
K851738	Mcdb-105 Med. M6395, W/l-Glutamine, 25M M Herpes &	Sigma	KIT	Class I	1985-05-15
K851737	Mcdb-110 Med. M6520 W/l-Glutamine-25M M Herpes &	Sigma	KIT	Class I	1985-05-15
K851609	Sfre 199-2 Medium, Products No. S2138	Sigma Chemical Co.	KIT	Class I	1985-05-15
K851608	Sfre199-1 Medium Product No. S 2013	Sigma Chemical Co.	KIT	Class I	1985-05-15
K851607	Mcdb 151 Medium, Product No. M6645	Sigma Chemical Co.	KIT	Class I	1985-05-15
K851606	D-Pbs, Products No. D5652	Sigma Chemical Co.	KIT	Class I	1985-05-15
K851605	Swin's S-77 Medium, Products S2513	Sigma Chemical Co.	KIT	Class I	1985-05-15
K851604	Crcm-30 Medium Product No. C5030	Sigma Chemical Co.	KIT	Class I	1985-05-15
K851396	Sander's Maskcpap by Respironics	Respironics, Inc.	BYE	Class II	1985-05-15
K851369	Antinuclear Antibody Test Kit	Modern Diagnostics, Inc.	DHN	Class II	1985-05-15
K851337	502 Resuscitatory Inhalator Valve	Life Support Products, Inc.	BTL	Class II	1985-05-15
K851302	Quinton Q-Tel 418T & 419T Remote Cardiac Monitor	Quinton, Inc.	DRG	Class II	1985-05-15
K851276	Action Pac	South Mountain Medical	LDQ		1985-05-15
K851274	Ohmeda Model 0001/0003 Recorder	GE Healthcare	DSF	Class I	1985-05-15
K851245	Addition of 50% Oxygen to Applinc Saving Breath Hy	Applinc	BZE	Class II	1985-05-15
K851139	Thumper Cardiopulmonary Resuscitator 1005	Michigan Instruments	DRM	Class II	1985-05-15
K851124	T-1000 ECG Transmitter	Brentwood Instruments, Inc.	DXH	Class II	1985-05-15