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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 1934 of 3531

510(k) clearances, page 1934 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K964016	Tielle Hydropolymer Foam Dressing	Johnson & Johnson MEDICAL GmbH	KMF	Class I	1996-12-31
K964006	Incare Hot/ice System Blankets (Various Sizes and Shapes)	Hollister, Inc.	ILO	Class II	1996-12-31
K963951	As 123 Prosthetic Instrumentation System	BioHorizons Implant Systems Inc	DZE	Class II	1996-12-31
K963184	Olympus Subcutaneous Endoscopy System	OLYMPUS Corporation of the Americas	GCJ	Class II	1996-12-31
K964563	Omni Grip Latex Examination Glove, Powder-Free	Omni Sales Corp.	LYY	Class I	1996-12-30
K964545	Powder Free Vinyl Examination Glove	Shanghai Poseidon Plastic Products Co., Ltd.	LYZ	Class I	1996-12-30
K964177	Kromalgin Impression Material	North American Orthodontic Laboratories, Inc.	ELW	Class II	1996-12-30
K964120	Injecto Flush	Robert J. Jynch, Jr.	FCL	Class I	1996-12-30
K961342	Shoe Cover, Non-Sterile	Copioumed Intl., Inc.	FXP	Class I	1996-12-30
K960999	Isolation Gown	Copioumed Intl., Inc.	FYC	Class II	1996-12-30
K955661	Acu-Halt	Glederer & Co., Inc.	LDQ		1996-12-30
K955425	Dash, Sullivan, Vital Gard Hypoallergenic with Protein Content Labeling Claim	Dash Medical Gloves Sdn Bhd	LYY	Class I	1996-12-30
K964262	Exactech Total Hip Systme: 22Mm Femoral Head	Exactech, Inc.	JDI	Class II	1996-12-27
K964163	Trimax Nail System	Smith & Nephew Richards, Inc.	HSB	Class II	1996-12-27
K964150	Whiteside Biomechanics Zirconia Ceramic Femoral Head	Whiteside Biomechanics, Inc.	LZO	Class II	1996-12-27
K964008	Foundation Knee System	Encore Orthopedics, Inc.	JWH	Class II	1996-12-27
K963985	Um-D3000/um-D4000	J.J. Consulting Services, Inc.	GEI	Class II	1996-12-27
K962486	Depuy Motech Anterior Compression Plate System	Depuy, Inc.	KWQ	Class II	1996-12-27
K962309	Alternate Encapsulating Resin System for Mca Hemodialyzers	Althin Medical AB an Affiliate of Baxter Intl	FJI	Class II	1996-12-27
K961992	Needle's Eye Snare	Cook Pacemaker Corp.	DXE	Class II	1996-12-27
K953111	Corail	Landos, Inc.	LZO	Class II	1996-12-27
K964669	Miracle-Ear or Audiotone	Miracle-Ear, Inc.	ESD	Class I	1996-12-26
K963938	Model 5500 Ceas	Esa, Inc.	CHQ	Class I	1996-12-26
K962435	Stc Auto-Lyte Urinary Glucose Assay	OraSure Technologies, Inc.	CFR	Class II	1996-12-26
K962418	Urea Nitrogen (Bun) Liqui-UV	Stanbio Laboratory	CDQ	Class II	1996-12-26
K962037	Imagen Respiratory Screen	Dako Diagnostics, Ltd.	GNW	Class I	1996-12-26
K961405	Alba Health Pas Wrap System	Alba-Waldensian, Inc.	JOW	Class II	1996-12-26
K964637	Culture Collection and Transport System, Modified Amies Media	Medical Packaging Corporation	JSM	Class I	1996-12-24
K964116	Quinidine Assay for the Technicon Immuno 1 System (in Vitro Diagnostic System)	Bayer Corp.	LBZ	Class II	1996-12-24
K964060	Copaxone (Copolymer-1 for Injection) Self-Injection Administration Package	Travenol Laboratories (Israel), Ltd.	FMF	Class II	1996-12-24
K963972	Neo-Care Dual Lumen Umbilical Catheter	Klein-Baker Medical, Inc.	FOS	Class II	1996-12-24
K963847	Wako Direct Hdl-C	FUJIFILM Healthcare Americas Corporation	JIS	Class II	1996-12-24
K962601	Nichols Advantage Chemiluminescence Adrenocorticotropic Hormone	Nichols Institute Diagnostics	CKG	Class II	1996-12-24
K961780	Hemodialysis Introducer Set	Merit Medical Systems, Inc.	DYB	Class II	1996-12-24
K961209	Brio Automatic Samplinc Unit	Seac S.r.l.	JJF	Class I	1996-12-24
K960915	Clarus Neuropen Endoscopic Placement Kit Model 2125-Xxx	Clarus Medical Systems, Inc.	GWG	Class II	1996-12-24
K964794	Dahlberg K-Amp Bte	Miracle-Ear, Inc.	ESD	Class I	1996-12-23
K964659	Orthoralix E/gx-9000 Panoramic X-Ray System	Dentsply Intl.	EHD	Class II	1996-12-23
K964618	Cyto-Stat Trichrome Cd8-Fitc/cd4-Rdi/cd3-Pc5 Monoclonal Antibody Reagent with Cyto-Stat Trichrome Msiggi-Fitc/msiggi-Rd1	Coulter Corp.	GKZ	Class II	1996-12-23
K964471	Rep Flur Cholesterol-60 Kit	Helena Laboratories, Corp.	JHO	Class I	1996-12-23
K964453	Rep 3 Flur Spe-60 Kit	Helena Laboratories, Corp.	CEF	Class I	1996-12-23
K964376	Cide-Swipes P-100B & Cide-Swipes C-100A	Mp Scientific, Inc.	LRJ	Class I	1996-12-23
K964196	Continuous Flow System, Cfs-1 Pump System (4-700-00)	Northgate Technologies Inc.	OCX	Class II	1996-12-23
K964125	Convertors Drape Material	Medtronic, Inc.	KKX	Class II	1996-12-23
K964031	Dcl8 Enhanced Pulsed Nd:yag Laser System	Slt-J, Ltd.	GEX	Class II	1996-12-23
K963980	Philips Easyvision	Philips North America LLC	LLZ	Class II	1996-12-23
K963952	Series 9600 Mobile Digital Imaging System	GE Dec Medical Systems	OWB	Class II	1996-12-23
K963860	The Nomos Talon Positioning and Immobilization System	Nomos Corp.	IYE	Class II	1996-12-23
K963795	Vision-Sciences Model B-F100 Bronchoscope with Model Bs-F21 Disposable Endosheath	Cogentix Medical, Inc.	EOQ	Class II	1996-12-23
K963762	Corneal Topographer 200	Eclipse Ventures	MMQ	Class I	1996-12-23