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 2173 of 3531

510(k) clearances, page 2173 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K942711	Neitz Halogen Ophthalmoscope Bxa-123	Neitz Instruments Company, Ltd.	HLI	Class II	1994-08-05
K942533	Novalens/novawet Perception and Vanguard	Ocutec Corporation, Inc.	HQD	Class II	1994-08-05
K942528	Integrapost	Dental Logics, Inc.	ELR	Class I	1994-08-05
K942510	Scipotex Powder Free Exam Gloves (Unbeaded)	Wembley Rubber Products (M) Sdn Bhd	LYY	Class I	1994-08-05
K942478	Visard Frames	Iris Optical, Inc.	HQZ	Class I	1994-08-05
K942450	Endopath	Ethicon Endo-Surgery Inc	GBZ	Class I	1994-08-05
K942438	Altair 6100 Cassette Recorder	Burdick Corp.	DSH	Class II	1994-08-05
K942419	Hydro-S Wound Gel	Hymedix Intl., Inc.	MGQ	Unclassified	1994-08-05
K942302	Addvantage 38 Aspheric Soft Contact Lens	Preferred Optics, Inc.	LPL	Class II	1994-08-05
K942221	Irrigation Tray with Piston Syringe	Trinity Laboratories, Inc.	FMF	Class II	1994-08-05
K942042	Powder Free Vinyl Patient Examination Gloves	Cheer & Merit Co., Ltd.	LYZ	Class I	1994-08-05
K941938	The Mirage System Biofeedback Interface	Intercare Diagnostics, Inc.	HCC	Class II	1994-08-05
K941766	Dib Infusor	Novacon Corp.	MEB	Class II	1994-08-05
K941605	Stryker Femoral Canal Brush, Acetabular Brush	Stryker Corp.	LXH	Class I	1994-08-05
K941464	Basics Endoscopy System	Cox Medical Ent., Inc.	OCZ	Class II	1994-08-05
K935407	Stickit	EM Innovations Inc	FMI	Class II	1994-08-05
K935166	Flow Directed Mikro-Tip Pressure Transducer	Millar LLC.	DXO	Class II	1994-08-05
K934781	Bvr High Torque Heads	Bvr Aero Precision Corp.	EGS	Class I	1994-08-05
K934468	Slip-on Fixation Splint (Sfs)	Gatewood Splints	EHO	Class I	1994-08-05
K933843	Line Extension for Kirschner Performance Total Knee System, Porous Coated	Kirschner Medical Corp.	JWH	Class II	1994-08-05
K933542	Mesial Loop Bar	Gac Intl., Inc.	ECO	Class I	1994-08-05
K932057	Browne Tst Single Use Bowie Dick Type Test Pack	Board of Directors, Albert Browne, Ltd.	JOJ	Class II	1994-08-05
K920757	Filtral Hemodialyzers	C.G.H. Medical, Inc.	KDI	Class II	1994-08-05
K913255	Ceramic(tm) Abutment	Ceramic Core Corp.	DZE	Class II	1994-08-05
K943328	Everything Kids	Jcc Co., Inc.	HQY	Class I	1994-08-04
K943258	Hydrocolloid Wound Dressing	Convatec, A Division of E.R. Squibb & Sons	KMF	Class I	1994-08-04
K943183	Ciba Vision(r) Contact Lens Case	Alcon Laboratories	LRX	Class II	1994-08-04
K943161	Orvis Driving Glasses	The Orvis Co., Inc.	HQY	Class I	1994-08-04
K943117	Intra-Sonix Urofiber	Intra-Sonix, Inc.	GCJ	Class II	1994-08-04
K943085	Spectacle Frame	Winntics Optical Industry Co. Ltd.	HQZ	Class I	1994-08-04
K943082	Spectacle Frame	Daewon Optical Co.	HQZ	Class I	1994-08-04
K942845	Persol, Mosclhino, and Gerald Genta	Persol America, Inc.	HQZ	Class I	1994-08-04
K942270	Saf-Gel Hydrating Dermal Wound Dressing	Calgon Vestal Div.	KMF	Class I	1994-08-04
K942104	Keeler Vantage Indirect Ophthalmoscope	Keeler Instruments, Inc.	HLI	Class II	1994-08-04
K941148	Sunglasses	Metal Dream S.r.l.	HQY	Class I	1994-08-04
K940670	Earcraft Hearing Aid	Earcraft, Inc.	ESD	Class I	1994-08-04
K940561	Sunglasses	Hibiscus Ind. Co., Ltd.	HQY	Class I	1994-08-04
K940088	Medical Technical Products Standard Ultrasonic Handpiece	Medical Technical Products, Inc	HQC	Class II	1994-08-04
K936125	Spectacle Frames, Sunglasses	Eyedesigns Corp.	HQY	Class I	1994-08-04
K931653	Spine-Tech Cervical Fixation System	Spinal Technologies	KWQ	Class II	1994-08-04
K943364	Corassist Wound Dressing	Calgon Corp.	KMF	Class I	1994-08-03
K943184	Lorrex Health Prod Cotton Filled Sponges Sterile 2'S	Lorons International Corp.	EFQ	Unclassified	1994-08-03
K942955	Disposable Bipolar Electrode	Neuro Navigational Corp.	GWG	Class II	1994-08-03
K942926	Neuro-Aide	Burke Neutech, Inc.	GWY	Class I	1994-08-03
K942824	Lorrex IV Sponges, Sterile 2'S; Lorrex Drain Sponges, Sterile 2'S	Lorrex Health Products	EFQ	Unclassified	1994-08-03
K942692	Lorrex Health Products-Fluff Gauze Rolls; Gauze Conforming Bandages Sterile and Non Sterile	Lorons International Corp.	EFQ	Unclassified	1994-08-03
K942217	Pulsejet Dental Laser System	Incisive Technologies Pty Ltd	GEX	Class II	1994-08-03
K941869	Splint, Pneumatic, Arm & Splint, Pneumatic, Leg	Lighthouse for the Blind	KZF	Class I	1994-08-03
K941684	Ivex-2 Extension Set with Y-Injection Site	Abbott Medical	FPB	Class II	1994-08-03
K940801	K-Klip	Katecho LLC	DRX	Class II	1994-08-03