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 2895 of 3529

510(k) clearances, page 2895 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K860315	Neurotech-16 Program System Controller Model 280	Neurotech, Inc.	IPF	Class II	1986-06-17
K860314	Neurotech-4 Program Neuromuscular Stimulator 281	Neurotech, Inc.	IPF	Class II	1986-06-17
K853696	Rubella Igg Eia Test Kit	Labsystems, Inc.	LFX	Class II	1986-06-17
K862154	Venesection Equipment Storage Tray	Rmp Co.	FSM	Class I	1986-06-16
K862152	Tissue Culture Flask Pl 732 Plastic Accessory Prod	Travenol Laboratories, S.A.	KJA	Class I	1986-06-16
K862123	Biosphere Anaerobic Environmental Device	Marion Laboratories, Inc.	KZJ	Class I	1986-06-16
K862120	Scx System	General Electric Co.	JAA	Class II	1986-06-16
K862118	Model Mba-130 Mobile X-Ray System	Elscint, Inc.	IZL	Class II	1986-06-16
K862067	Stratus Digitoxin Fluorometric Enzyme Immunoassay	American Dade	LFM	Class II	1986-06-16
K861946	Ptk Plus. Home Pregnancy Test	Healthcheck Corp.	LCX	Class II	1986-06-16
K861920	Simultrac Neonatal T4(57co)/tsh(125i) Radioimmuno.	BD Becton Dickinson Vacutainer Systems Preanalytic	JLW	Class II	1986-06-16
K861855	Hydroxybutyrate Dehydrogenase (Hbd) Reagent Set	Sterling Diagnostics, Inc.	JKF	Class I	1986-06-16
K861847	Acs Rotating Hemo Valve - Dual Access Type	Advanced Cardiovascular Systems, Inc.	LOX	Class II	1986-06-16
K861677	Pharmaseal Medi-Vac Intra-Oper. Autotransfus. Kit	American Pharmaseal Div. Ahsc	CAC	Class II	1986-06-16
K861552	Top-Port Enteral Feeding Bag and Preattached Sets	Entech, Inc.	KNT	Class II	1986-06-16
K861541	Sheridan - Ysi/ecg Sonatemp (Tm)	Sheridan Catheter Corp.	BZT	Class II	1986-06-16
K861385	Milex Bartholin Gland Catheter	Milex Products, Inc.	KNA	Class II	1986-06-16
K861279	Fluoro Plus	Advantage Medical Systems, Inc.	LLZ	Class II	1986-06-16
K861187	Sceptor Gram Negative Breakpoint /Id Panel	BD Becton Dickinson Vacutainer Systems Preanalytic	JWY	Class II	1986-06-16
K861070	Coloplast Convex Ring	MEDLINE INDUSTRIES, LP - Northfield	EXB	Class I	1986-06-16
K860855	Shur Gel 4	Columbus Dental Mfg. Co.	ELW	Class II	1986-06-16
K860776	Matrix Lr, Lr 22A & Lr/laser Recorder	Matrix Instruments	LMC	Class II	1986-06-16
K860553	Storz, Alpha II Biometric Ruler	Storz Instrument Co.	ITX	Class II	1986-06-16
K860081	Esi 2000 Diagnostic Ultrasound System Transducers	Elscint, Inc.	IYO	Class II	1986-06-16
K854959	Linear Scanner Probe, Model Tl-50	Elscint, Inc.	IYO	Class II	1986-06-16
K854847	Physio-Dyne Ecg/hr 3	Physio-Dyne Industrument Corp.	DRT	Class II	1986-06-16
K854493	Erg 555 Couch Ergometer	Robert Bosch Corp.	DRT	Class II	1986-06-16
K854492	Erg 551 Ergometer, Bicycle	Robert Bosch Corp.	DRT	Class II	1986-06-16
K854491	Erg 550 Ergometer Bicycle	Robert Bosch Corp.	DRT	Class II	1986-06-16
K852960	Direct	University of Wisconsin	CGA	Class II	1986-06-16
K862199	Medtech c.p.r. Mask	The Medtech Group, Inc.	CAE	Class I	1986-06-13
K862145	Jedmed Mini-Mos Video Camera	JEDMED Instrument Company	FWD	Class I	1986-06-13
K862141	Histology Paraffin	Erie Scientific Co.	KEO	Class I	1986-06-13
K862112	Microscope Slides	Abco Dealers, Inc.	LIB	Class I	1986-06-13
K862027	Ldp Reagent Cartridge (No. 88216)	Hi Chem, Inc.	CFJ	Class II	1986-06-13
K861968	Amresco Flow Pac Inorganic Phosphrus Reagent Set	American Research Products Co.	CEO	Class I	1986-06-13
K861967	Amresco Flow Pac Sodium Potassium Reagent Set	American Research Products Co.	JGS	Class II	1986-06-13
K861945	Lee-Bead Prolactin (Eia)	Leeco Diagnostics, Inc.	CFT	Class I	1986-06-13
K861935	Model 100 Nerve Stimulator	National Medical Sales, Inc.	BXN	Class II	1986-06-13
K861922	Titanium Hemostatic Clips	Pilling Co.	FZP	Class II	1986-06-13
K861820	Biosil F	Degussa Dental, Inc.	EJH	Class II	1986-06-13
K861785	Fluoroscope Band Bag	Medi-Plast Intl., Inc.	JAA	Class II	1986-06-13
K861735	Tipsep-Tbg Assay	Nuclear Diagnostics, Inc.	CEE	Class II	1986-06-13
K861663	Total Protein Procedure	Data Medical Associates, Inc.	CEK	Class II	1986-06-13
K861660	Uric Acid Procedure	Data Medical Associates, Inc.	KNK	Class I	1986-06-13
K861659	Cholesterol Procedure	Data Medical Associates, Inc.	CHH	Class I	1986-06-13
K861654	Albumin Procedure	Data Medical Associates, Inc.	CIX	Class II	1986-06-13
K861511	Emit Caffeine Control	Syva / A Syntex Co.	LAS	Class I	1986-06-13
K861506	Document Enzyme Linearity Test Sets	Casco Standards	JJT	Class I	1986-06-13
K861458	Murex Suds Toxo	Murex Corp.	LGD	Class II	1986-06-13