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 2159 of 3531

510(k) clearances, page 2159 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K941964	Lmt Arthroscopic Suturing Instruments	Li Medical Technologies, Inc.	HRX	Class II	1994-09-28
K941141	Precision Ostelock Sp Femoral Component	Howmedica Corp.	LPH	Class II	1994-09-28
K941036	Curved Rotatable Disposable Arthroscopic Surgery Blades	Smith & Nephew, Inc.	HRX	Class II	1994-09-28
K941006	Sunglasses	Opti-Ray, Inc.	HQY	Class I	1994-09-28
K940798	Shippert Pressure Bandage	Denver Splint Co.	KGX	Class I	1994-09-28
K940290	Acufex Acl Sheath for Interference Screws	Acufex Microsurgical, Inc.	HRX	Class II	1994-09-28
K940283	Karl Storz Endovision Urocam/hysterocam	Medical Concepts	FET	Class II	1994-09-28
K940083	Standard Phaco Tip 15, 30, 45, 60	Medical Technical Products, Inc	HQC	Class II	1994-09-28
K936205	Comprehensive Phoropter, Mdr-680	Canon Medical Components U.S.A., Inc.	HKN	Class I	1994-09-28
K936200	Wireless Chart Projector,hcp-W 721	Canon Medical Components U.S.A., Inc.	HOS	Class I	1994-09-28
K936199	Automatic Lensometer	Canon Medical Components U.S.A., Inc.	HLM	Class I	1994-09-28
K935198	Gastroenterology and Urology Guidewire Modifications	Lake Region Mfg., Inc.	KNT	Class II	1994-09-28
K933275	P.f.c. Ceramic Hip Head	Johnson & Johnson Orthopaedics, Inc.	LZO	Class II	1994-09-28
K933014	Lifestream Centrifugel Pump Interface #210Pi	Abbott Medical	KFM	Class II	1994-09-28
K931963	Sandhill Disposable Internal Reference Ph Probe	Diversatek Healthcare Inc	FFT	Class I	1994-09-28
K931478	Zeiss Opmi L Stereo-Laparoscope	Carl Zeiss, Inc.	HET	Class II	1994-09-28
K930623	Microvasive Insurg Biliary Balloon Dilatition Cath	Boston Scientific Corporation	FGE	Class II	1994-09-28
K926581	Mic Transgastric Jejunal Tube	Medical Innovations, Inc.	KNT	Class II	1994-09-28
K926417	Alphatec 130-150 Slotted Compression Hip Screw	Alphatec Spine, Inc.	KTT	Class II	1994-09-28
K944414	Dekalb	Endotec, Inc.	GCJ	Class II	1994-09-27
K944400	Pedi-Cap	Nellcor, Inc.	CCK	Class II	1994-09-27
K943728	Burnfree Burnsoothe Hydrogel	Levtrade Intl. (Pty), Ltd.	MGQ	Unclassified	1994-09-27
K943470	Burnfree Burnsoothe Hydrogel Burn Blotts	Levtrade Intl. (Pty), Ltd.	MGQ	Unclassified	1994-09-27
K943056	Single Stick Radially Expanding Dilator	Innerdyne Medical, Inc.	GCJ	Class II	1994-09-27
K942944	Irrigation/bipolar Set	Surgin Surgical Instrumentation, Inc.	GEI	Class II	1994-09-27
K942934	Conbio Cub-D10 Cooper Laser System	Continuum Biomedical, Inc.	GEX	Class II	1994-09-27
K935309	Lung Diffusion	Acetylene Gas Co.	BZC	Class II	1994-09-27
K932837	Consensus Knee System - Primary Knee	U.S. Medical Products, Inc.	JWH	Class II	1994-09-27
K932114	Tubal Lumen Support	Cook Ob/Gyn	HFJ	Class II	1994-09-27
K925333	Single Use Tungsten Wire Lee Loop Electrode	Aspen Labs	HGI	Class II	1994-09-27
K925143	Model 4800 Accupace Pacing System Analyer	Pace Medical	DTE	Class II	1994-09-27
K944433	Surgi-Link Electrosurgical Electrode	Unimed Surgical Products, Inc.	GEI	Class II	1994-09-26
K943434	Patient Examination Gloves	Pacewell Sdn Bhd	LYY	Class I	1994-09-26
K943044	Royal Shield Non-Sterile Latex Exam Gloves-Strawberry	Shield Gloves Manufacturer (M) Sdn Bhd	LYY	Class I	1994-09-26
K943043	Royal Shield Non-Sterile Latex Exam Gloves-Bubble Gum	Shield Gloves Manufacturer (M) Sdn Bhd	LYY	Class I	1994-09-26
K942272	Igm Rheumatoid Factor	Immco Diagnostics, Inc.	DHR	Class II	1994-09-26
K941563	The Biopsy Tool	Citation Medical Corp.	FCG	Class II	1994-09-26
K940228	Bouffant Cap	Derekduck Industries Corp.	LYU	Class I	1994-09-26
K940226	Shoe Cover	Derekduck Industries Corp.	LYU	Class I	1994-09-26
K934580	Dantec 13R45 Bar Electrode	Dantec Medical, Inc.	GXY	Class II	1994-09-26
K934040	The Osteoreport	Woodson and Associates, LLC	KGI	Class II	1994-09-26
K930786	Epcor	Siemens Medical Solutions USA, Inc.	DRW	Class II	1994-09-26
K922440	Steriking, See & Peel	Cox Sterile Products, Inc.	KCT	Class II	1994-09-26
K913360	Anti-Reticulin Antibody (Ara) Test	Immco Diagnostics, Inc.	DBL	Class II	1994-09-26
K944304	Origin Balloon Anchor	Origin Medsystems, Inc.	GCJ	Class II	1994-09-23
K944031	Video Scope System (Otoscope)	JEDMED Instrument Company	ERA	Class I	1994-09-23
K943865	Force Gsu-Slpm System	Medtronic, Inc.	GEI	Class II	1994-09-23
K943826	Miracle-Ear Mirage	Miracle-Ear, Inc.	ESD	Class I	1994-09-23
K943805	Prestige Remote R & F System Models H, Vh & Vhd	General Electric Co.	JAA	Class II	1994-09-23
K943607	Interacoustics Hearing Aid Analyzer Ms 40	Precision Acoustics Ind., Inc.	ETW	Class II	1994-09-23