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 2855 of 3529

510(k) clearances, page 2855 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K861985	3M Brand Microvascular Anastomotic Coupler (27Xx)	3M Company	MVR	Class II	1986-12-04
K861725	Intracath Intravenous Catheter Placement Unit	Parke-Davis Co.	FOZ	Class II	1986-12-04
K853733	Med-Pen/med-Point	Garid, Inc.	CGA	Class II	1986-12-04
K850449	Digital Pulse Meter Hrm-100E & Etc.	Sanyo Electric, Inc.	DRT	Class II	1986-12-04
K864473	Seminal Fluid Collection Kit(tm)	Apex Technologies, Inc.	HIS	Class II	1986-12-03
K864329	Models 54601/54602/54603/54604 Needle & Biopsy Kit	Dlp, Inc.	KNW	Class II	1986-12-03
K864207	Disposable Test Cards/gamma Slide Test Infect Mono	Gamma Biologicals, Inc.	KTN	Class II	1986-12-03
K864142	Ubi Magiwel(tm) Ige Quantitative and Qualitative	United Biotech	DGC	Class II	1986-12-03
K863794	3M Igg4 Fast Test Package	3M Company	DHB	Class II	1986-12-03
K863681	Pathfinder(tm) Direct Antigen Detection System	Kallestad Laboratories, Inc.	LJP	Class I	1986-12-03
K863642	Candela Model Mdl-1 Laser Lithotriptor	Candela Corporation	FFK	Class II	1986-12-03
K863607	Vibratron II, Vibration Sensitivity Tester	Sensortek, Inc.	LLN	Class I	1986-12-03
K863428	Single Use Laser Fiber Delivery System for Nd: Yag	Laser Media	LNK	Class II	1986-12-03
K863394	Rapid Specific Ige Procedure	Allertec, Inc.	DHB	Class II	1986-12-03
K863327	Immpulse Ige Assay Reagents	Sclavo, Inc.	DGP	Class II	1986-12-03
K863312	Sandhill Ams	Sandhill	FAP	Class II	1986-12-03
K863190	Choice Condom	Select Sources, Inc.	HIS	Class II	1986-12-03
K862907	P-S Medical Csf-Siphon Control Device	Pudenz-Schulte Medical Research Corp.	JXG	Class II	1986-12-03
K862087	Santest 1Ap	Scientific Sales Intl., Inc.	LKL	Class I	1986-12-03
K864477	Foundations Plus Girdle Support Garment 5000	Foundations Plus, Inc.			1986-12-02
K864427	Kneecpm	Invacare GmbH	BXB	Class I	1986-12-02
K864010	Empi Model 712, Logix(tm), Nms	Empi	IPF	Class II	1986-12-02
K863935	Toshiba Tct-600 Computed Tomography (CT) X-Ray	Toshiba Medical Systems	JAK	Class II	1986-12-02
K863805	Miller/galante Total Knee Por Coated Patellar Dome	Zimmer GmbH	JWH	Class II	1986-12-02
K863193	Sentinel 4 EEG Analyzer	Axon Systems, Inc.	GWQ	Class II	1986-12-02
K862177	Idex Dental Implant	R. J. Chapman, D.M.D.	DZE	Class II	1986-12-02
K864556	Aqualube(tm)	Parker Laboratories, Inc.	KMJ	Class I	1986-12-01
K864555	3 Ring Attachment	Professional Medical Services	FMF	Class II	1986-12-01
K864459	Rail Clamp Extension Piece	American Container Technology, Inc.	FWZ	Class I	1986-12-01
K864397	Disposable Pharmaseal Temperature Monitoring Probe	American Pharmaseal Div. Ahsc	FLL	Class II	1986-12-01
K864342	Multipurpose Immunochemistry System La-2000 Latex	Eiken Chemical Co., Ltd.	CFN	Class II	1986-12-01
K864289	Microprocessor Contr/multi-Needle, Galvan Epilator	Alexander Thomas, Inc.	KCW	Class I	1986-12-01
K863973	Elm Allergen Disc	Immuno Nuclear Corp.	DHB	Class II	1986-12-01
K863931	Carbonet Odour Adsorbing Dressing	Smith & Nephew, Inc.			1986-12-01
K863930	Viscopaste Zinc Paste Bandage	Smith & Nephew, Inc.	FRO	Unclassified	1986-12-01
K863750	Hickman(tm) Subcutaneous Port W/detached Catheter	C.R. Bard Inc	LJT	Class II	1986-12-01
K863288	Hydrophilic Reprosil	Dentsply Intl.	ELW	Class II	1986-12-01
K864454	Thermostable Nuclease Test Agar	Dimed, Intl.	JSH	Class I	1986-11-28
K864418	Landers Indirect Vitrectomy Lens	Ocular Instruments, Inc.	HJK	Class II	1986-11-28
K864343	Bl1 (Hard Contact Lens)	Beta Labs, Inc.	HPX	Unclassified	1986-11-28
K864266	Ophthalmic Knife & Forceps	Western Medical Products, Inc.	HNR	Class I	1986-11-28
K864230	Dimension (Tm) Clinical Chemistry System	E.I. Dupont de Nemours & Co., Inc.	CKE	Class II	1986-11-28
K864183	Ophthalmic Surgical Instruments	Techno Ophthalmics Intl.	HNR	Class I	1986-11-28
K864060	Micro-Reader	Hyperion, Inc.	JJQ	Class I	1986-11-28
K863963	Emds(tm) Aspartate Aminotransferase (Ast) 67657/95	Em Diagnostic Systems, Inc.	CIT	Class II	1986-11-28
K863962	Emds(tm) Alanine Aminotransferase (Alt) #67658/95	Em Diagnostic Systems, Inc.	CKA	Class I	1986-11-28
K863813	Toxoplasma Igg Microassay	Diamedix Corp.	LGD	Class II	1986-11-28
K863796	Creative Care Systems' IV Start Kit	American Biomaterials Corp.	LRS	Class II	1986-11-28
K863408	Ebv/vca-Check(tm) Antigen Slides	Diagnostic Technology, Inc.	GNP	Class I	1986-11-28
K862165	Electronic Ultrasound Scanner, Model Eub-340	Hitachi Medical Corp. of America	IYO	Class II	1986-11-28