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 1283 of 3531

510(k) clearances, page 1283 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K043178	Grantalder Rhapsody Access Port and Catheter	Grantadler Corportation	LJT	Class II	2006-02-02
K053443	Biogel Eclipse Non-Pyrogenic Latex Powder-Free Sterile Surgeon's Glove	Regent Medical Americas, LLC	KGO	Class I	2006-02-01
K053421	Yag Mir Family Laser	Cynosure, LLC	GEX	Class II	2006-02-01
K053403	Lucas	Jolife AB	DRM	Class II	2006-02-01
K053178	Symmetry S-Series Piezoelectric Scaling Tips	HU-Friedy Mfg. Co. LLC	ELC	Class II	2006-02-01
K053170	Preformance Posts	ZimVie US Corp LLC	NHA	Class II	2006-02-01
K053103	Interface	Apex Dental Materials, Inc.	KLE	Class II	2006-02-01
K052991	Radiancy Facial Skincare Device	Radiancy (Israel), Ltd.	GEX	Class II	2006-02-01
K052731	Kangsheng Brand/kangnian Brand/unilink Brand/huazhong Brand Acupuncture Needles	Daxin LI	MQX	Class II	2006-02-01
K052608	Telephone Based Bl Healthcare Remote Care Management System (Rcms)	Bl Healthcare, Inc.	DRG	Class II	2006-02-01
K060136	Planar Dome Ex Series Digital Flat-Panel Display System, Model E4c Color	Planar Systems, Inc.	LLZ	Class II	2006-01-31
K060078	Fibered Idc Occlusion System	Boston Scientific Corporation	KRD	Class II	2006-01-31
K060031	Depuy Modular M Heads	Depuy Orthopaedics Inc.	LPH	Class II	2006-01-31
K060006	Braun Thermoscan Irt 2000 Infrared Ear Thermometer	Braun GmbH	FLL	Class II	2006-01-31
K053228	Therigraft Tcp Putty Bone Void Filler	Therics, Inc.	MQV	Class II	2006-01-31
K053226	Zimmer Ambulatory Pump Pain Management Systems with Fenestrated Catheter and Flow Splitter	Zimmer GmbH	FRN	Class II	2006-01-31
K053177	Medtronic Minimed Paradigm Insulin Pump, Model Mmt-712E	Medtronic, Inc.	LZG	Class II	2006-01-31
K053156	Mini-Wright Digital, Model 3120001	Clement Clarke Intl., Ltd.	BZH	Class II	2006-01-31
K053112	Biosign	Oxford Biosignals Limited	MWI	Class II	2006-01-31
K053028	Techdevice Guidewire	Techdevice Corporation	OCY	Class II	2006-01-31
K052930	Navigator Endoscopy System	Neoguide Systems, Inc.	FDF	Class II	2006-01-31
K052438	EMG Handle Nebulizer Nb02 Series	EMG Technology Co., Ltd.	CAF	Class II	2006-01-31
K051648	Spotchem II Inoganic Phosphorus, Cpk and Uric Acid Tests	Arkray, Inc.	CGS	Class II	2006-01-31
K051163	Galix ECG Professional Station	Galix Biomedical Instrumentation, Inc.	DPS	Class II	2006-01-31
K050952	Hph Junior High Performance Hemoconcentrator	Medivators Inc	KDI	Class II	2006-01-31
K053631	Contour Transtar Curved Cutter Stapler Set	Ethicon Endo-Surgery Inc	GDW	Class II	2006-01-30
K053548	Modified Pva-Plus Foam Embolization Particles and Maxistat and Microstat Pva Foam Embolization Particles	Protein Polymer Technologies, Inc.	HCG	Class II	2006-01-30
K053208	Clear Vision Embryo Transfer Catheter Set, Model B100000 - B 100007; Clear Vision Trial Transfer Catheter Set	Swemed Lab International AB	MQF	Class II	2006-01-30
K053176	Duckworth & Kent Ltd Cartridge Lens Delivery System, Model Dk7797	Duckworth & Kent, Ltd.	MSS	Class I	2006-01-30
K053124	Boston Es (Enflufocon a), Boston Eo (Enflufocon B) and Boston Xo (Hexafocon a) Rigid Gas Permeable Contact Lenses	Bausch & Lomb Incorporated	HQD	Class II	2006-01-30
K052654	Klockner Dental Implant, Model S3m	Soadco, S.L.	DZE	Class II	2006-01-30
K053311	Stryker Scope Warmer	Stryker Corp.	GCJ	Class II	2006-01-27
K053270	Ivent 201	Versamed Medical Systems, Inc.	CBK	Class II	2006-01-27
K053091	Procera Implant Bridge Zirconia	Nobel Biocare AB	NHA	Class II	2006-01-27
K053086	Mie - Gamma Camera Systems	Mie America, Inc.	KPS	Class II	2006-01-27
K052959	Durex Male Colored Latex Condoms with Scented Lubricants	Ssl Americas, Inc.	HIS	Class II	2006-01-27
K052951	Endopore Anatomic Endosseous Dental Implant System	Innova Life Sciences Corp.	DZE	Class II	2006-01-27
K052918	Reprocessed External Fixation Devices	Alliance Medical Corp.	KTT	Class II	2006-01-27
K052915	Profemur Xtr Hip Stem	Wrightmedicaltechnologyinc	KWA	Class III	2006-01-27
K052649	Drg Slv Testosterone Elisa Test	Drg Intl., Inc.	CDZ	Class I	2006-01-27
K052534	Tacahe	Dalton Medical Corp.	ITI	Class II	2006-01-27
K051028	Breeze	Afikim Electric Vehicles	INI	Class II	2006-01-27
K060071	Nexa Compression Screw	Nexa Orthopedics, Inc.	HWC	Class II	2006-01-26
K060027	Architect Dhea-S Calibrators (a-F) and Controls (Low, Medium and High)	Biokit, S.A.	JJX	Class I	2006-01-26
K060026	Koby Surgical Internal Fixation System	Koby Surgical	HWC	Class II	2006-01-26
K053642	Osteoset Dbm Pellets	Wrightmedicaltechnologyinc	MBP	Class II	2006-01-26
K053630	Levitronix Centrimag Primary Console	Levitronix, LLC	DWA	Class II	2006-01-26
K053518	Interv Brand V-Mark Breast Biopsy Site Marker with Titanium Anchor	Medical Device Technologies, Inc.	NEU	Class II	2006-01-26
K053516	Mucohard	Parkell, Inc.	EBI	Class II	2006-01-26
K053514	Triathlon Total Knee System	Stryker Orthopaedics	JWH	Class II	2006-01-26