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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2567 of 3530

510(k) clearances, page 2567 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K896812	Carbon Dioxide Reagent	Horiba Instruments Incorporated	KHS	Class II	1990-02-23
K896744	Benzodiazepines/tricyclic Antidepressants by Hplc	Bio-Rad	JXM	Class II	1990-02-23
K896387	Sxt-60F/60m Mobile C Arm X-Ray Unit	Toshiba America Medical Systems, In.C	OXO	Class II	1990-02-23
K895274	Hypex	Global Business, Inc.	BYW	Class I	1990-02-23
K895147	Quantum Qad-1E Angiodynograph Ultrasound System	Quantum Intl.	IYO	Class II	1990-02-23
K894992	Quantum Qad Angiodynograph Ultrasound System	Quantum Medical Systems, Inc.	MAA	Class II	1990-02-23
K900738	Booster Motorized Three Wheeled Vehicle	Burke Mobility Products	INI	Class II	1990-02-22
K900588	Acu-Band Accupressure Wrist Band	Euro-Am Pharma, Inc.	MVV	Unclassified	1990-02-22
K900238	Miracle Ear Model Sk in-the-Ear Hearing Aid	Miracle-Ear, Inc.	ESD	Class I	1990-02-22
K900237	Miracle Ear Model Sm in-the-Ear Hearing Aid	Miracle-Ear, Inc.	ESD	Class I	1990-02-22
K900115	Ventlab Exhalation Manifold Vx-2000 a & Vx-2000 B	Salter Labs	CAN	Class I	1990-02-22
K900059	Biopotential Surface Electrode	Integral Design, Inc.	GXY	Class II	1990-02-22
K897157	Optilase Yag Model 1000 Acv Surgical Laser System	Trimedyne, Inc.	GEX	Class II	1990-02-22
K897152	Cragg Convertible Wire	Boston Scientific Corporation	DQX	Class II	1990-02-22
K896961	Halux Exlite Minor Surgery Light	JEDMED Instrument Company	GBC	Class II	1990-02-22
K896798	Tracheostomy Tray	Westmark, Sterile Packing Systems, Inc. (Sps)	BTO	Class II	1990-02-22
K896719	Primer-P Adhesive Agent	Parkell, Inc.	EBI	Class II	1990-02-22
K896718	Bicore Variflex(r) Flow Transducer	Bicore Monitoring Systems	BYR	Class I	1990-02-22
K896667	Lorenz Stent	Biomet Microfixation	FWN	Class II	1990-02-22
K896649	Granitec Z2, Zinc Phosphate Cement	Confi-Dental Products Co.	EMA	Class II	1990-02-22
K896397	S-Rom(tm)/noiles(tm) Mark 5 Knee	Joint Medical Products Corp.	JWH	Class II	1990-02-22
K895987	Keller Pulse Oximeter - Kms 850	Keller Medical Specialties Products, Inc.	DQA	Class II	1990-02-22
K895971	Telectronics Pacing Systems Vs-1 to 6Mm Upsizing	Telectronics Pacing Systems, Inc.	DTD	Class II	1990-02-22
K895955	Loper Celiac Plexus Block Catheter Kit	Opticon Medical, Inc.	CAZ	Class II	1990-02-22
K895895	Model 219 Telemetry System	Mennen Medical, Inc.	GYE	Class II	1990-02-22
K895740	Shower Chairs;bed/stretcher;linen & Utility Cart	Lumex, Inc.	FPO	Class II	1990-02-22
K895656	Accu-Beam Waveguide	Tti Medical	GEX	Class II	1990-02-22
K895638	Steam Sterilizer (Autoclave), Dental	Precision Fluidics Division Parker Hannifin Corp.	FLE	Class II	1990-02-22
K895269	Den-Mat Lami-Quick	Den-Mat Corp.	ELL	Class II	1990-02-22
K895230	Sterile Surgeon's Gloves (C T R Gloves)	Tan D. W. Trading Co., Inc.	KGO	Class I	1990-02-22
K895001	Type Expired CO2 9270, Capnograph	S & W Medico Teknik	CCK	Class II	1990-02-22
K893229	Spatula for Pap Smear Collection	Medical Device Inspection Company	HHT	Class II	1990-02-22
K900478	Woodlyn Full Aperture Trial Lens Set	Woodlyn, Inc.	HPC	Class I	1990-02-21
K900477	Woodlyn Classic Slit Lamp Model Smm	Woodlyn, Inc.	HJO	Class II	1990-02-21
K900476	Woodlyn Slit Lamp Model Hr-1	Woodlyn, Inc.	HJO	Class II	1990-02-21
K900244	3M Multi-Allergen Ige Fastscreen(tm) S8	3M Company	DGC	Class II	1990-02-21
K900108	3M Multi-Aller. Ige Fastscreen S9 W1,6,9,10,11,12	3M Company	DGC	Class II	1990-02-21
K897156	Hydrasorb(tm)	Avitar, Inc.	NAD	Class I	1990-02-21
K900600	Tri-Scoot Front Wheel Drive Powered Scooter	Invacare GmbH	INI	Class II	1990-02-20
K900581	Danniflex Cpm 880(Tm)	Buckman Co., Inc.	JFA	Class I	1990-02-20
K900290	Skytron Model 1100 and Model 142	Skytron, LLC	JEA	Class I	1990-02-20
K896908	Excel Stim II	Excel U.S.A.	IPF	Class II	1990-02-20
K896836	Excel Stim	Excel Tech., Ltd.	IPF	Class II	1990-02-20
K896814	Toi-Lift	Mill-Tech Ent., Inc.	INN	Class I	1990-02-20
K896728	4 Sure Urinary Leg Bag	The Boston & Pacific Co., Inc.	FAQ	Class I	1990-02-20
K896727	4 Sure Urinary Drain Bag	The Boston & Pacific Co., Inc.	KNX	Class II	1990-02-20
K895983	Multistim Plus	Excel Tech., Ltd.	IPF	Class II	1990-02-20
K895690	Ultra (Therapeutic Ultrasound Device)	Excel Tech., Ltd.	IMG	Class II	1990-02-20
K895654	Sorbex(tm) Soft Sponge	Fountain Pharmaceuticals, Inc.	NAD	Class I	1990-02-20
K895301	Ems 8100	Henley Intl.	IPF	Class II	1990-02-20