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 2026-10-19, 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 3039 of 3529

510(k) clearances, page 3039 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K842150	Transducer-Monitor Interfacing	Millar LLC.	DXO	Class II	1984-10-26
K841597	Gil-Med Parenteral Nutrition or Medicine	Gil-Med Industries C/O Kegan & Kegan, Ltd.	KPE	Class II	1984-10-26
K841336	Non-Invasive Bp Module 7000	Marquette Electronics, Inc.	DXN	Class II	1984-10-26
K841103	Noninvasive Blood Pressure Measure Sys	Panasonic Co. Div. Matsu Elec. Corp. America	DXN	Class II	1984-10-26
K840646	Cardiotrode	Kholber Corp.	DRX	Class II	1984-10-26
K840587	Instant Replay	Instromedix, Inc.	DXH	Class II	1984-10-26
K840524	Servomed Basic Bedside Unit Smv 110Tp	Litton Medical Electronics	DRT	Class II	1984-10-26
K840376	Surg-a Stat Loop Tip	Suncoast Medical Manufacturers, Inc.	GEI	Class II	1984-10-26
K840036	Fitex	Britt Corp., Inc.			1984-10-26
K840032	Telephone Receivers R101 R111	Biometric Products, Inc.	DXH	Class II	1984-10-26
K840020	Fitness Logger	Britt Corp., Inc.	DPS	Class II	1984-10-26
K833689	Diascope 2	S & W Medico Teknik	DRT	Class II	1984-10-26
K832833	Personal Defibrillator	Physio Control, Inc.	LDD	Class II	1984-10-26
K832076	Electronic Blood Press. Meter En-212	Panasonic Co. Div. Matsu Elec. Corp. America	DXN	Class II	1984-10-26
K844092	Diagnostic Microsopce Slides	Sybron Corp.			1984-10-25
K844055	Esophageal Stetho Scope	Sensortek, Inc.	BZT	Class II	1984-10-25
K844040	Servo Humidifier 152 Siemens-Elema Ab	Siemens Elema AB	BYD	Class I	1984-10-25
K843896	Rheumadx Latex Agglutination Rheumatoid	Siemens Healthcare Diagnostics Inc.	DHR	Class II	1984-10-25
K843886	Scented Breathable Private Label Mini-Sh	I.C.D. Industries, Inc.	HHL	Class II	1984-10-25
K843814	Emumol Ultraviolet Suntanning Lamp	Mottek Intl. Corp.	FTC	Class II	1984-10-25
K843801	Mason Equipment Organizer & Aspen	Aspen Laboratories, Inc.	FSE	Class I	1984-10-25
K843745	Adp Ana Applezyme	Apple Diagnostic Products	LJM	Class II	1984-10-25
K843741	Rpr Test Reditest	Biokit USA, Inc.	GMP	Class II	1984-10-25
K843735	Softepil	Nemectron Medical, Inc.	KCX	Class I	1984-10-25
K843734	Nemdi	Nemectron Medical, Inc.	KCX	Class I	1984-10-25
K843721	Disposable Isolation Gown	Anago, Inc.			1984-10-25
K843690	Illinois Sternum/iliac Aspiration Needle	Popper & Sons, Inc.	GDM	Class I	1984-10-25
K843664	Mycoplasma Pneumoniae	Institute Virion, Ltd.	GSB	Class I	1984-10-25
K843647	Mti 1200, 401 & 3500	Manufactured Tan Intl.	FTC	Class II	1984-10-25
K843586	Thora-Klex Autotransfusion Kit	C.R. Bard Inc			1984-10-25
K843582	Multi-Format Film Camera	Bfi- Medical Waste Systems	LMC	Class II	1984-10-25
K843371	Valvotomy Knife	Downs Surgical, Ltd.	EMF	Class I	1984-10-25
K843363	Restodent Vl	Lee Pharmaceuticals	EBF	Class II	1984-10-25
K843234	Citomat Autoclaves	Lic-Orthion	ECG	Class I	1984-10-25
K843233	Anatom System	Lic-Orthion	KLC	Class I	1984-10-25
K843025	Command Enamel-Dent Dental Adhesive	Kerr Corporation (Danbury)	KLE	Class II	1984-10-25
K843023	Kerr Porcelain Repair Primer	Kerr Corporation (Danbury)	KLE	Class II	1984-10-25
K842973	Hayfever Helmet	R.H. Hinchli Fle & Sons, Ltd.	FRF	Class II	1984-10-25
K842845	Bone Mill Bone Grinder	Acromed Corp.			1984-10-25
K842637	Uniflow Vent Tube	Richards Medical Co., Inc.	ETD	Class II	1984-10-25
K842621	Suture Strip	Genetic Laboratories, Inc.	FPX	Class I	1984-10-25
K842563	Seratest DNA Determination	Seragen Diagnostics, Inc.	LKJ	Class II	1984-10-25
K842191	Digistore 50	Vas Corp.	JAA	Class II	1984-10-25
K843984	Pm-80 Pulmotester	Future Impex Corp.	BZG	Class II	1984-10-24
K843970	Model Im1074 End-Tidal CO2 Module	Gould, Inc.	CCK	Class II	1984-10-24
K843733	Api Uniscept Kb	Analytical Products, Inc.	LTW	Class II	1984-10-24
K843732	Api Uniscept Mic	Analytical Products, Inc.	LTD	Class III	1984-10-24
K843709	Cobe Saturation Cell	Cobe Laboratories, Inc.	DRY	Class II	1984-10-24
K843700	St-200A W/maximal Voluntary Ventillat-	Future Impex Corp.			1984-10-24
K843617	Sdc Silicone Sump Drain	Science Development Corp.	GBX	Class I	1984-10-24