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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3203 of 3528

510(k) clearances, page 3203 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K820948	Three Second Thermometer #Ts-1000	Temp-Stik Corp.	FLL	Class II	1982-09-24
K822696	Master I	Master Medical Services, Inc.	INI	Class II	1982-09-22
K822435	Medi-Therm Skin Thermometer	Everest Interscience, Inc.	FLL	Class II	1982-09-22
K822355	Disp. Metal & Plastic Electrosurg. Dev	Medtronic, Inc.	GEI	Class II	1982-09-22
K822354	Disposable Plastic Transfus./infus. Assb	Medtronic, Inc.	FPA	Class II	1982-09-22
K822250	Myo-Tone, Inc. System-80	Myo-Tone, Inc.	IPF	Class II	1982-09-22
K822693	Acu-Massage Table	H.W.E., Inc.	JFB	Class II	1982-09-21
K822686	Denver Peritoneo-Venous Shunt (Dp-Vs)	Denver Biomedicals, Inc.	KPM	Class II	1982-09-21
K822685	Neb-Travel Nts-1000 & Nts-3000 Therapy	Certified Respiratory Services, Inc.	BTI	Class II	1982-09-21
K822665	Wilkins-Chalgren Anaerobe Broth	Oxoid U.S.A., Inc.	JSC	Class I	1982-09-21
K822664	Pseudomonas Agar Base, C-N & C-F-C Supp	Oxoid U.S.A., Inc.	JSJ	Class I	1982-09-21
K822663	Febrile Antigen Kit	Oxoid U.S.A., Inc.	GSO	Class II	1982-09-21
K822662	Reagin Antigen Suspension	Oxoid U.S.A., Inc.	GMQ	Class II	1982-09-21
K822661	Rapid Reagin Card Test	Oxoid U.S.A., Inc.	GMQ	Class II	1982-09-21
K822660	Vogel Johnson Agar	Oxoid U.S.A., Inc.	JSJ	Class I	1982-09-21
K822659	Yersinia Agar Base & Supplement	Oxoid U.S.A., Inc.	JSJ	Class I	1982-09-21
K822644	Riwolith 2135	R. Wolf Medical Instruments Corp.	FFK	Class II	1982-09-21
K822615	Life Watch Lsi	Life Science Instrumentation, Inc.	DRT	Class II	1982-09-21
K822614	Blood Pressure Monitoring Devices	Allied Medical LLC	DXN	Class II	1982-09-21
K822597	Guide Wire	Vertex Medical Corp.	DQX	Class II	1982-09-21
K822596	Vertex Percutaneous Puncture Needle	Vertex Medical Corp.	DQO	Class II	1982-09-21
K822587	Advance Emit-Cad Quinidine Control	Syva Co.	DLJ	Class II	1982-09-21
K822582	Quikpage Scanner	Agilent Technologies, Inc.	DPS	Class II	1982-09-21
K822572	Polyhesive Patient Return Electrode	Medtronic, Inc.	GEI	Class II	1982-09-21
K822518	Csm Beta-Lactamase Disc	Carr-Scarborough Microbiologicals, Inc.			1982-09-21
K822513	Model #2000 Hi-Temp & #3000 Low-Temp	Surgicare Scientific Laboratory, Inc.	GEI	Class II	1982-09-21
K822512	Repco Easy-Breather Clinical Air Pump	Repcocarts USA, Inc.	BTI	Class II	1982-09-21
K822496	Sera Chem Smac Calibrators	Fisher Scientific Company L.L.C.	JIT	Class II	1982-09-21
K822494	Optimized UV-Gpt Reagent Set	Biorent Diagnostic, Inc.	CKA	Class I	1982-09-21
K822493	Optimized UV-Got Reagent Set	Biorent Diagnostic, Inc.	CIT	Class II	1982-09-21
K822487	Minitek Gram-Positive Broth & Set and	BD Becton Dickinson Vacutainer Systems Preanalytic	JSC	Class I	1982-09-21
K822482	Surgilite Non-Woven Wrap	Surgilite Intl., Inc.	FRG	Class II	1982-09-21
K822456	Ohio V5a Anesthesia Ventilator	Airco/Ohio Medical Products	CBK	Class II	1982-09-21
K822438	Biomega Model 59W	Bio Mega Diagnostic, Inc.	DXN	Class II	1982-09-21
K822405	Conductive Adhesive Dispersive Electro	Edward Weck, Inc.	GEI	Class II	1982-09-21
K822403	Lact-Assist Breast Pump	Lact-Assist, Inc.	HGY	Class I	1982-09-21
K822397	Ana Hep-2 Fluoro-Kit	Clinical Sciences, Inc.	DHN	Class II	1982-09-21
K822394	Ticarcillin Syscept. Disks	Beecham Laboratories	JTN	Class II	1982-09-21
K822390	Life Trace 24	Life Science Instrumentation, Inc.	DRT	Class II	1982-09-21
K822389	Life Trace 40/42	Life Science Instrumentation, Inc.	DRT	Class II	1982-09-21
K822345	Disposable Linear Stapler (Lsf)	Ethicon, Inc	GDW	Class II	1982-09-21
K822316	Heart Monitor Bracelet Alarm	Hmba	DRI	Class I	1982-09-21
K822285	Cellulose Acetate Membrane Strips	Sartorius Filters, Inc.	JJN	Class I	1982-09-21
K822179	Frenzel Eyeglasses & Related Items	Kelleher Corp.	KHH	Class I	1982-09-21
K822093	Stat-Scan	Survival Technology, Inc.	DXG	Class II	1982-09-21
K822092	Cameron-Miller #40-1516	Cameron-Miller, Inc.	GEI	Class II	1982-09-21
K822066	Legionella Pneumophila	Biodan Medical Systems, Ltd.	LHL	Class II	1982-09-21
K822651	Total Finger Flexion Splint	Alimed, LLC	ILH	Class I	1982-09-17
K822607	Antinuclear Antobody Cell Substrate	Immulok, Inc.	DHN	Class II	1982-09-17
K822602	Hemacount Wright Giemsa Stain Pack	Accra Laboratories, Inc.	JAF	Class II	1982-09-17