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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2705 of 3530

510(k) clearances, page 2705 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K883441	Vision(r) Prothrombin Time	Abbott Medical	GJS	Class II	1988-09-13
K883428	Biotrol Uric Acid Enzymatique Trinder	Biotrol, USA, Inc.	KNK	Class I	1988-09-13
K883405	Triglycerides Reagent (Product #88218)	Hichem Diagnostics	CDT	Class I	1988-09-13
K883404	Uric Acid Reagent (Product #88219)	Hichem Diagnostics	KNK	Class I	1988-09-13
K883396	Handswitching Monopolar Pencil	New England Surgical Instrument Corp.	GEI	Class II	1988-09-13
K883353	Iq Hdl Cholesterol	BD Becton Dickinson Vacutainer Systems Preanalytic	LBR	Class I	1988-09-13
K883342	Ventrex Coated Tube Tsh	Ventrex Laboratories, Inc.	JLW	Class II	1988-09-13
K883302	Emax Precision Microplate Reader	Molecular Devices Corp.	JJQ	Class I	1988-09-13
K883269	Prl-Quant	Leeco Diagnostics, Inc.	CFT	Class I	1988-09-13
K883247	Lipophor(tm) Syst, Human Serum Lipoprotein Control	Quantimetrix Medical Industries	JJY	Class I	1988-09-13
K883209	Technicon Ra-100(Tm) System	Technicon Instruments Corp.	JJE	Class I	1988-09-13
K883195	Fresenius F8 Dialyzer	Fresenius USA, Inc.	KDI	Class II	1988-09-13
K882689	Punch Myringotomy System	Xomed, Inc.	ETD	Class II	1988-09-13
K882295	Filling Volume Option	Eris Medical Technology	LJH	Class II	1988-09-13
K882218	Compat (R) Enteral Delivery System	Sandoz Nutrition	KNT	Class II	1988-09-13
K882089	Mrm Gastrostomy Belt	Mrm Products, Inc.	KNT	Class II	1988-09-13
K875280	Steris System 1 Processor and 20 Sterilant	Steris C/O Medical Device Consultants, Inc.	MED	Class II	1988-09-13
K883575	Modified Site Mobile Stand for Ophthalmic Use	Site Microsurgical Systems, Inc.	HMG	Class I	1988-09-12
K883431	Raymax 2100 Models 2130 & 2136	Raymax Medical Corp.	IZO	Class I	1988-09-12
K883344	Heartstart 1000S	Laerdal Mfg. Corp.	MKJ	Class III	1988-09-12
K883341	Heartstart 1000	Laerdal Mfg. Corp.	MKJ	Class III	1988-09-12
K883254	Multinex Monitor (Modification)	Datascope Corp.	CCL	Class II	1988-09-12
K883095	Mx860, Reusable Pressure Transducer	Medex, Inc.	DRS	Class II	1988-09-12
K882879	Pti Intra-Art(tm) Coronary Artery Occluders (Ster)	Pioneering Technologies, Inc.	DXC	Class II	1988-09-12
K882762	Collagen Shield	Chiron Ophthalmics	MOE	Class I	1988-09-12
K882476	Opus Pulse Generators Models 3001, 3003 and 3004	Ela Medical, Inc.	DXY	Class III	1988-09-12
K882474	Opus Pulse Generators Models 2001, 2003 and 2004	Ela Medical, Inc.	DXY	Class III	1988-09-12
K881469	Angioscope W/integrated Irrigating Channel	Baxter Healthcare Corporation	FER	Class II	1988-09-12
K881049	Bradbury Intraocular Retinal Kit Cat #200	Microline Pentax, Inc.	HNR	Class I	1988-09-12
K880288	Tru-Trac Torque Guidewire	N-S Medical Products	DQX	Class II	1988-09-12
K880287	Tru-Trac Coiled Guidewire	N-S Medical Products	DQX	Class II	1988-09-12
K883459	Double Antibody Benzodiazpines #Kbzd1, Kbzd5	Siemens Healthcare Diagnostics Inc.	JXM	Class II	1988-09-09
K883279	Phase II Fsh Kit	Vitek Systems, Inc.	CGJ	Class I	1988-09-09
K883206	Lactate Dehydrogenase Ldh	Electro-Nucleonics, Inc.	CFJ	Class II	1988-09-09
K883205	Altlts Alanine Amino Transferase Alt	Electro-Nucleonics, Inc.	CKA	Class I	1988-09-09
K883190	Dade Tdm Control	Baxter Healthcare Corporation	DIF	Class I	1988-09-09
K883085	T3 Uptake Serozyme Enzyme Immuno Kt/mag Solid Phas	Serono Diagnostics, Inc.	KHQ	Class II	1988-09-09
K883012	A.qc Chemistry Control Level 2	Arden Medical Systems, Inc.	JJY	Class I	1988-09-09
K882941	Blood Gas Mixture	Swisco, Inc.	CHL	Class II	1988-09-09
K882938	Stat Fax(tm)	Awareness Technology, Inc.	JJQ	Class I	1988-09-09
K882926	Model Au-1 Accessory Unit	Directed Energy, Inc.	GEX	Class II	1988-09-09
K882734	Ktp/yag(tm) Surgical Laser	Laserscope	GEX	Class II	1988-09-09
K882647	Gesco Catheterization Tray	Gesco Intl., Inc.	GBQ	Class I	1988-09-09
K882536	Ophthalmic Pao Valve	Look, Inc.	FMF	Class II	1988-09-09
K882506	Modified American Lubricating Jelly, 2.7 & 5.0	Span-America Medical Systems, Inc.	KMJ	Class I	1988-09-09
K882403	Ophthalmic Fluid Injector	Trek Medical Products, Inc.	FMF	Class II	1988-09-09
K882379	Minim-X 2001-Cias & Minim-X 2002-Cias	Dentomar, Inc.	EAP	Class II	1988-09-09
K882002	Pregnagen(tm)	Biogenex Laboratories, Inc.	JHI	Class II	1988-09-09
K881631	Biodynamics Autotransfusion Reservoir	Biodynamics Corp.	CAC	Class II	1988-09-09
K881616	Pmt Mankind Lumbar-Peritoneal Shunt Model 1115-1	Progress Mankind Technology	JXG	Class II	1988-09-09