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 1999 of 3531

510(k) clearances, page 1999 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K952909	Autozone	Health Scan, Inc.	BZH	Class II	1996-03-29
K952713	Mini Wright Lr Afs	Clement Clarke, Inc.	BZH	Class II	1996-03-29
K960910	Indermil Dental	Loctite Corp.	EMA	Class II	1996-03-28
K960719	Star Dental 430 Series High Speed Handpiece	Dentalez Group	EFA	Class I	1996-03-28
K960653	Monocryl (Poliglecaprone 25) Suture, Dyed (Modified)	Ethicon, Inc	GAN	Class II	1996-03-28
K960541	Lynx Dpa Disposable Prophy Angle	Mti Precision Products	EFB	Class I	1996-03-28
K960525	Bemis One Quart Phlebotomy Container (Part Number 100)	Bemis Mfg. Co.	MMK	Class II	1996-03-28
K960507	Star Dental Pushbutton Autochuck Replacement Turbine for Midwest Handpieces	Dentalez Group	EFA	Class I	1996-03-28
K960380	Seesoft (Polymacon) Soft (Hydrophilic) Aspheric Contact Lens	Unilens Corp., USA	LPL	Class II	1996-03-28
K960376	Freesoft (Polymacon) Soft (Hydrophilic) Aspheric Contact Lens	Unilens Corp., USA	LPL	Class II	1996-03-28
K960365	Alpha-Dent Hema Desentizer(748-000)/With Fluoride(747-000)	Wallace A. Erickson & Co.	KLE	Class II	1996-03-28
K960288	Ha & Tps Restore Self Tapping Dental Implant System	Lifecore Biomedical LLC	DZE	Class II	1996-03-28
K960260	Star Titan Series Motors & Attachments	Dentalez Group	EFA	Class I	1996-03-28
K960238	CPR Suture Removal Kit	Custom Pack Reliability	FRG	Class II	1996-03-28
K960236	CPR Lap Sponges	Custom Pack Reliability	GDY	Class I	1996-03-28
K960223	CPR Yankauer	Custom Pack Reliability	GCX	Class II	1996-03-28
K960218	Connecting Tubing	Custom Pack Reliability	BYY	Class II	1996-03-28
K960217	CPR Urine Bag	Custom Pack Reliability	FAQ	Class I	1996-03-28
K960208	CPR Basic Set-Up Tray	Custom Pack Reliability	FRG	Class II	1996-03-28
K960185	Amsino Clinical Thermometer	Amsia Intl., Inc.	FLK	Class II	1996-03-28
K960171	Active Crosslaps Elisa	Diagnostic Systems Laboratories, Inc.	JMM	Class I	1996-03-28
K960051	Nipro Safelet Cath	Nissho Corp.	FOZ	Class II	1996-03-28
K960026	Biohorizons Dental Implant System	BioHorizons Implant Systems Inc	DZE	Class II	1996-03-28
K955909	Mouse Anti-Human Cd3, T-Cell, Fitc & Cd8, T-Cell(suppressor/cytotoxic) Rpe	Dako Corp.	GKZ	Class II	1996-03-28
K955901	Storz Dp4310deluxe Phaco Pack without Reflux	Storz Instrument Co.	HQC	Class II	1996-03-28
K955831	Argyle Aspr-Care Closed Suction System	Sherwood Medical Co.	BSY	Class I	1996-03-28
K955366	Trans-Aire Rigid Gas Permable Contact Lens	Rand Scientific Corp.	HQD	Class II	1996-03-28
K955329	Resilience M5 Protection Plus	Confi-Dental Products Co.	DYH	Class II	1996-03-28
K955328	Confi-Bond	Confi-Dental Products Co.	KLE	Class II	1996-03-28
K954524	W-55 (Methafilon a) Contact Lens	Westcon Contact Lens Co., Inc.	LPL	Class II	1996-03-28
K954428	Solopicc 24 (60Cm) 20Ga Catheter	Douglas Medical Products, Inc	FOZ	Class II	1996-03-28
K960538	Opteon Unipolar	Exactech, Inc.	KWL	Class II	1996-03-27
K960489	Ultra IV	Excel Tech., Ltd.	IPF	Class II	1996-03-27
K960385	Sterile Kirschner Wires and Steinmann Pins	Depuy, Inc.	HTY	Class II	1996-03-27
K960255	Ceramic Blade Electrode	Utah Medical Products, Inc	GEI	Class II	1996-03-27
K960235	Sensititre 18 Hour Susceptibility Plates	Accumed Intl., Inc.	JWY	Class II	1996-03-27
K960172	Depuy Porocoat Hps II Hip Prosthesis W/articul-Eze Taper	Depuy, Inc.	LPH	Class II	1996-03-27
K960111	Kis Mt4	Implant Center of the Palm Beaches	DZE	Class II	1996-03-27
K960096	Ultra III	Excel Tech., Ltd.	IPF	Class II	1996-03-27
K960094	Reflection Dual Dimension Shell	Smith & Nephew Richards, Inc.	MBL	Class II	1996-03-27
K960043	Kodak Cardiology Digital Archive & Review System	Jamieson Film Co.	LLZ	Class II	1996-03-27
K955739	Modular Acetabular Shell II	Intermedics Orthopedics	LPH	Class II	1996-03-27
K955636	Sentry Disposable Dispersive Electrode	Sentry Medical Products, Inc.	JOS	Class II	1996-03-27
K955365	Compact Cotrel-Dubousset (Ccd) Spinal System	Sofamor Danek USA,Inc.	KWP	Class II	1996-03-27
K955047	Westmed Circularie Pep Devices	Westmed Intl.	BYE	Class II	1996-03-27
K954943	Nevoscope	Nizar A. Mullani	KZF	Class I	1996-03-27
K954692	CPR Prompt	County Line, Ltd.	LIX	Class II	1996-03-27
K951998	Diasonics Masters Series 5000 Ultrasound Scanner	Diasonics Ultrasound	IYN	Class II	1996-03-27
K951448	Global Medical Products Potts Cournand, Seldinger Style Needle, Single, Winged Single Wall Introducer Needle	Global Medical Products, Ltd.	DRC	Class II	1996-03-27
K935123	Superstand 300	Wuestec Medical, Inc.	IYB	Class I	1996-03-27