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 1308 of 3531

510(k) clearances, page 1308 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K051740	Tapered Compression Pin	Nexa Orthopedics, Inc.	JDW	Class II	2005-09-06
K051661	Implant Handpieces	Sirona Dental Systems GmbH	EKX	Class I	2005-09-06
K051616	Vanguard Reprocessed External Fixation Devices	Stryker Sustainability Solutions	KTT	Class II	2005-09-06
K051611	Mbaresorb Implant	Kinetikos Medical, Inc.	HWC	Class II	2005-09-06
K051585	F-400 System	Mauna Kea Technologies	GCJ	Class II	2005-09-06
K051556	Acumatch a-Series Connexion Gxl Enhanced Crosslinked Polythylene	Exactech, Inc.	LPH	Class II	2005-09-06
K051192	Praxair Medical Air Mixer	Praxair, Inc.	BZR	Class II	2005-09-06
K050435	E-Stim II	Lhasa Oms, Inc.	GZJ	Class II	2005-09-06
K052334	Cavitron RF Ultrasonic Scaler System with Sterimate Handpiece, Model G-131	Dentsply Intl.	ELC	Class II	2005-09-02
K052296	Clirpath Turbo Excimer Laser Catheters	Spectranetics Corp.	PDU	Class II	2005-09-02
K052149	Edwards Peripheral Dilation Catheter	Edwards Lifesciences LLC	DQY	Class II	2005-09-02
K052076	Dar-8000I	Shimadzu Medical Systems	IZI	Class II	2005-09-02
K051924	Powdered Vinyl Patient Examination Gloves, Colored (White, Yellow)	Shijiazhuang Manful Light Industrial Products Co.	LYZ	Class I	2005-09-02
K051910	Maxisonic Family and Swift Ultrasonic Scaler	D.B.I. America Corp.	ELC	Class II	2005-09-02
K051874	Sedline Sedation Monitor with Frontal Psi and Sedtrace EEG Electrose Set	Physiometrix, Inc.	OLW	Class II	2005-09-02
K051671	Radiancy Skinstation with Modified Light Unit Addembly	Radiancy (Israel), Ltd.	GEX	Class II	2005-09-02
K051594	Mccartney Access Tube	Gynetech Pty., Ltd.	HEW	Class II	2005-09-02
K051593	Uropass Ureteral Access Sheath, Model 61224	Acmi Corporation	KNY	Class II	2005-09-02
K051592	Modification to Accu-Chek Go System	Roche Diagnostics GmbH	LFR	Class II	2005-09-02
K051507	Modification to Blue Sky Bio Dental Implant System	Blue Sky Bio, LLC	DZE	Class II	2005-09-02
K051160	Manipuseal	Insitu Systems	HEW	Class II	2005-09-02
K051035	Synergeyes (Paflucon D Hem-Iberfilcon a) Hybrid Contact Lens	Synergeyes, Inc.	HQD	Class II	2005-09-02
K051018	Intermezzo Implant Systems	Megagen Co., Ltd.	DZE	Class II	2005-09-02
K050999	Yi Xin Sterile Syringe for Single Use	Jiangxi Sanxin (Eversincere) Medical Devices Group	FMF	Class II	2005-09-02
K050863	Imager II Angiographic Catheter	Boston Scientific Corporation	DQO	Class II	2005-09-02
K050629	Angiosculpt Scoring Balloon Catheter	Spectranetics Corp.	PNO	Class II	2005-09-02
K050443	Accu-Lead	Kentec Medical, LLC	DRX	Class II	2005-09-02
K050411	Zimmer A.t.s. 3000 Automatic Tourniquet System	Zimmer GmbH	KCY	Class I	2005-09-02
K043373	Dolotens Dental Tm 1	Neuromuscular Technologies, Inc.	KZM	Class II	2005-09-02
K042782	Seer Mc	GE Medical Systems Information Technologies, Inc.	MLO	Class II	2005-09-02
K052074	Jsz-Stat-Tree, and Jsz-Stat-or, Cleaning, Disinfecting and Storing Solutions; Jsz-Wet-Tree and Jsz-Wet-or, Wetting,	Szabocsik and Associates	MRC	Class II	2005-09-01
K052017	Cyclosporine Extended Range Assay (Csae) Flex Reagent Cartridge, Catalog # Df108	Siemens Healthcare Diagnostics Inc.	MKW	Class II	2005-09-01
K052016	Non-Sterile Powder Free Multicolor - Red, Blue, Purple and Yellow Latex Examination Gloves with Protein Content Labeling	Sgmp Co., Ltd.	LYY	Class I	2005-09-01
K051838	Modified Concentric Retriever, Model 90039	Concentric Medical, Inc.	DQY	Class II	2005-09-01
K051712	Model 2800 Pft Filter	Air Safety, Ltd.	BZG	Class II	2005-09-01
K051669	Tevadaptor Closed Drug Reconstitution and Transfer System	Migada Plant	LHI	Class II	2005-09-01
K051576	Avana Dental Implant System	Osstem Co., Ltd.	DZE	Class II	2005-09-01
K051515	Modified Acumen Sheath, Model Ttw 10-65	Acumen Medical, Inc.	DYB	Class II	2005-09-01
K051422	Dual Mode Up-Grade Forehead/underarm Thermometer Device	Medisim Ltd.	FLL	Class II	2005-09-01
K051264	Comfort and Inset Subcutaneous Infusion Sets for Use with Abbott Infusion Pumps	Unomedical A/S	FPA	Class II	2005-09-01
K051157	Instru-Safe Instrument Protection Systems	Micromedics, Inc.	KCT	Class II	2005-09-01
K051091	Synthograft	Bicon, LLC	LYC	Class II	2005-09-01
K050352	In-Vitro Diagnostic Vaginitis Test Kit	Ameritek Research, LLC	JTO	Class I	2005-09-01
K052251	Drystar Model 5500	Agfa Corp.	LMC	Class II	2005-08-31
K052198	Relieva Sinus Balloon Inflation Device	Acclarent Inc	LRC	Class I	2005-08-31
K052144	Tsrh Spinal System	Medtronic Sofamor Danek	NKB	Class II	2005-08-31
K052086	Encore Reverse Shoulder Prosthesis Humeral Stem Adapter	Encore Medical, LP	PHX	Class II	2005-08-31
K052060	Opti-Amp Dc-Powered	Intelligent Hearing Systems Corp.	GWL	Class II	2005-08-31
K052035	Canady Plasma Probes	Canady Technology, LLC	GEI	Class II	2005-08-31
K051473	Leardo, Avanticare Electrical Scootersm3021	Lerado China Limited	INI	Class II	2005-08-31