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 2905 of 3529

510(k) clearances, page 2905 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K861276	Tamper Proof Cap	Intl. Medical Industries	FMF	Class II	1986-05-05
K861223	The Jr. Partner Spectrophotometer	Pharmacia, Inc.	JJQ	Class I	1986-05-05
K861165	Pharmaseal Dual Lumen Catheter	American Pharmaseal Div. Ahsc	DQY	Class II	1986-05-05
K861146	Model K110sx Centrifuge	Jouan S.A.	JQC	Class I	1986-05-05
K861082	Cordis Cath Sheath Introduc/mid-Length Sheath Syst	Cordis US Corp.	DYB	Class II	1986-05-05
K860987	Mini-Chem Analyzer	Ocean Scientific, Inc.	JJQ	Class I	1986-05-05
K860465	Vision Sgot (Ast) - Addit. of Whole Blood Claim	Abbott Medical	CIT	Class II	1986-05-05
K860435	Model 500A Vascular Spectrum Analyzer W/cw Doppler	Multigon Industries, Inc.	DPT	Class II	1986-05-05
K854356	Stethoscope Electronic Stethoscope Sphygmomanomete	Fontaine Industries, Inc.	DQD	Class II	1986-05-05
K861625	Servo Gas Monitor 120	Siemens Elema AB	CCL	Class II	1986-05-02
K861540	Disposable Berman and Guedel Airways	Dryden Corp.	CAE	Class I	1986-05-02
K861492	Hearing Aid (All in the Ear)	Crystal Tone Hearing Instruments	ESD	Class I	1986-05-02
K861474	Pb253 to Pb254 Ir - Spectrometer Upgrade Kit	Datex Division Instrumentarium Corp.	CBQ	Class II	1986-05-02
K861470	#Cto 100 (Cervical Traction Orthosis 100)	Applied Medical Systems	HAX	Class II	1986-05-02
K861460	Solid State Continuous Flow Control Model W/k101	Widran Urological Group, Ltd.	LJK	Class II	1986-05-02
K861396	Handheld Dynamometer, Model #160 and #111	Spark Instruments & Academics, Inc.	HRW	Class I	1986-05-02
K861389	Pap Smear Kit	Intl. Cytobrush, Inc.	HHT	Class II	1986-05-02
K861352	R1698,r1701,r1215,r1700 & R860 Powered Tables	Tri W-G, Inc.	INQ	Class I	1986-05-02
K861350	R1436,r1697,r1699,r1564,r1216,r1214,r854 & R1213	Tri W-G, Inc.	INW	Class I	1986-05-02
K861348	R1361 & R1372 Measured Exercise Equipment	Tri W-G, Inc.	ISD	Class II	1986-05-02
K861347	R1596 Powered Exercise Equipment	Tri W-G, Inc.	IOL	Class I	1986-05-02
K861346	R1363 Paraffin	Tri W-G, Inc.	IMC	Class II	1986-05-02
K861340	R1750 and R1424 Powered Heating Units	Tri W-G, Inc.	IRQ	Class I	1986-05-02
K861334	Cilco Diamond Knives & Diamond Knife Linear Gauge	Cilco, Inc.	HNN	Class I	1986-05-02
K861319	Disposable Needle Counter (20-560)	Anago, Inc.	MMK	Class II	1986-05-02
K861318	Disposable Needle Counter (20-720)	Anago, Inc.	FMI	Class II	1986-05-02
K861317	Disposable Needle Counter (20-530)	Anago, Inc.	MMK	Class II	1986-05-02
K861316	Disposable Needle Counter (20-240)	Anago, Inc.	MMK	Class II	1986-05-02
K861308	Accupac Custom Pack Kerlix Squares	Geneva Laboratories, Inc.	EFQ	Unclassified	1986-05-02
K861307	Disposable Needle Counter	Anago, Inc.	MMK	Class II	1986-05-02
K861260	Pedabarograph	Biokinetics, Inc.	JFC	Class I	1986-05-02
K861240	Bechler Medical, Model 5000,The Wiz Holter Scanner	Mountain View Medical	DSI	Class II	1986-05-02
K861164	Osteomill Bone Grinder	Biodynamic Technologies, Inc.	LYS	Class I	1986-05-02
K861155	Emit Desipramine Assay	Syva Co.	LFG	Class II	1986-05-02
K861140	Programalith III Pulse Generator	Pacesetter Systems	DXY	Class III	1986-05-02
K861118	Orthojoin, Orthodontic Adhesive	Ortho Source	DYH	Class II	1986-05-02
K861046	Model 2100 Nd:yag Surgical Laser Urological Indica	Sharplan Industries, Inc.	LNK	Class II	1986-05-02
K860997	Gastrointestinal Cytology Brush	Endovations	FDX	Class II	1986-05-02
K860992	Vox Companion	Bloomfield Research and Development, Inc.	ESE	Class I	1986-05-02
K860991	Sclerotherapy Injection Catheter	Endovations	KNT	Class II	1986-05-02
K860981	Aspir-Vac Disposable Surgical Drain System	Sun Technologies	GCY	Class I	1986-05-02
K860950	Scm-400 Holter System	Fukuda Denshi USA, Inc.	DSI	Class II	1986-05-02
K860945	Directaclone Cg Slide Pregnancy Test	Pacific Biotech, Inc.	JHJ	Class II	1986-05-02
K860940	Micromedics Sterile, Disposable ENT Exam Kit	Micromedics, Inc.	ETF	Class I	1986-05-02
K860758	Vaco Suction Electrode Unit	Zimmer Elektromedizin GmbH	IPF	Class II	1986-05-02
K860526	Nova Balloon Thermodilution Pressure Trans Cath	Nova Medical Specialties	DXO	Class II	1986-05-02
K860508	Posid Sampler	bioMerieux, Inc.	JQW	Class I	1986-05-02
K860204	Angiomat 6000	Mallinckrodt Group, Inc.	DXT	Class II	1986-05-02
K860171	Voroba Programmable Auditory Comparator	Voroba Technologies Assoc.	KHL	Class II	1986-05-02
K860161	Heart Catheterization Tray	Medical Design Concepts, Inc.	DRE	Class II	1986-05-02