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 1777 of 3531

510(k) clearances, page 1777 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K983352	Ilo2088 Enchocheck or Ilo2088 Otocheck	Otodynamics, Ltd.	EWO	Class II	1998-12-11
K983351	Ilo292 Dp Echoport Plus Oae System	Otodynamics, Ltd.	EWO	Class II	1998-12-11
K983350	Ilo292 Dp Echoport Plus Oae System	Otodynamics, Ltd.	EWO	Class II	1998-12-11
K983348	Dynarex Tracheostomy Sponge	Dynarex Corp.	EFQ	Unclassified	1998-12-11
K983320	Royale Brand Latex Condoms Silicone Lubricant Colored-or Assorted Colors	Suretex Prophylactics (India), Ltd.	HIS	Class II	1998-12-11
K983313	Advanced Automatic Detector Selection Option for Glory	Elscint, Inc.	IZH	Class II	1998-12-11
K983242	Sirona C8 Dental Operative Unit with Accessories	Sirona Dental Systems GmbH	EIA	Class I	1998-12-11
K983227	Power Block	Kreativ, Inc.	EIE	Class I	1998-12-11
K983200	Injection/aspiration Needles Probes/devices-Tpi/tpi Flex	Ximed/Prosure/Injectx	GAA	Class I	1998-12-11
K982661	Cdr - Pan Model 4700	Schick Technologies, Inc.	MQB	Class II	1998-12-11
K982651	Corometrics Model 5700 and 2264 Watertight Transducer	Corometrics Medical Systems, Inc.	HEL	Class II	1998-12-11
K982543	Silverstreak Hydrophilic Guidewire	Medtronic, Inc.	DQX	Class II	1998-12-11
K982323	Olympus Um 2R/3r Ultrasonic Probes and Associated Ancillary Equipment, for Bronchial Use	OLYMPUS Corporation of the Americas	ITX	Class II	1998-12-11
K982078	Immulite Rubella Quantitative Igg, Catalog # Lkrbq1 (100 Tests), Lkrbq5 (500 Tests)	Siemens Healthcare Diagnostics Inc.	LFX	Class II	1998-12-11
K981678	Strata, Model V.o.95	Rosses Medical Systems	MUJ	Class II	1998-12-11
K981449	Sd-956 Ultrasound Therapy	Skylark Device Co., Ltd.	IMI	Class II	1998-12-11
K981253	Ultracon Ultrafiltrator	Interpore Intl.	FJI	Class II	1998-12-11
K980632	Duration II Tibial Inserts - Gas Plasma Sterilization	Howmedica Corp.	JWH	Class II	1998-12-11
K980626	Duration II Acetabular Components-Gas Plasma Sterilization	Howmedica Corp.	JDI	Class II	1998-12-11
K984379	Nellcor Puritan Bennett, 760 Ventilator System	Medtronic, Inc.	CBK	Class II	1998-12-10
K984191	Myoglobin Flex Reagent Cartridge	Siemens Healthcare Diagnostics Inc.	DDR	Class II	1998-12-10
K984099	Qbc Centrifugal Hematology Control	R & D Systems, Inc.	JPK	Class II	1998-12-10
K983833	Acticoat Composite Wound Dressing, Acticoat Composite Wound Dressing-Adhesive	Westaim Biomedical, Inc.	KMF	Class I	1998-12-10
K983801	The Aptus (Automated) Application of the Ebv-Vca Igm Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) Fo	Zeus Scientific LLC	LSE	Class I	1998-12-10
K983752	Alumina-Zinc Oxide Powders F and R	Harry J. Bosworth Co.	EMA	Class II	1998-12-10
K983525	Gore Revox Thyroplasty Implant	W. L. Gore & Associates, Inc.	MIX	Class II	1998-12-10
K983412	Medcomp H-Cath Triple Lumen Central Venous Access Catheter, Model Sic 12-3T	Medical Components, Inc.	LJS	Class II	1998-12-10
K983210	Algisite M	Smith & Nephew, Inc.	KMF	Class I	1998-12-10
K983187	Medsol Goldenberg Bone Marrow Biopsy Needle	Medsol Corp.	KNW	Class II	1998-12-10
K983183	Gyro Long-Life,black Pearl Eco, Ondine &Croma, Prestige, Bora, Aquilon, Mc2,mc3, Basch, Isolite, Optima, US, Plpe, Ca, P	Bien Air USA	EFB	Class I	1998-12-10
K983182	Aloe Therapy Oral Rinse	Carrington Laboratories, Inc.	OLR	Unclassified	1998-12-10
K982076	Amira Medical Atlast Blood Glucose Monitoring System	Amira Medical, Inc.	CGA	Class II	1998-12-10
K981946	Clearview Im	Unipath, Ltd.	KTN	Class II	1998-12-10
K981922	Light Duty Pneumatic Instrument Model Number Pad-100, Heavy Duty Pneumatic Instrument Model Pad-200, Light Duty Electri	MicroAire Surgical Instruments, LLC	QPB	Class II	1998-12-10
K980973	Medtronic Angiographic Catheter	Medtronics Interventional Vascular	DQO	Class II	1998-12-10
K973328	Intersource	International Brachytherapy S.A.	KXK	Class II	1998-12-10
K984277	Cardioimmune Cardiac Marker Control Levels 1,2, and 3	Medical Analysis Systems, Inc.	JJT	Class I	1998-12-09
K983964	Batch #6060 Conductive Gel	Skylark Device Co., Ltd.	GYB	Class II	1998-12-09
K983303	Innovative Technologies Hydrocolloid and Intelligent Hydrocolloid Wound Dressings	Innovative Technologies, Ltd.	MGP	Unclassified	1998-12-09
K983274	Startrack Infant Graphics Monitor	Medtronic, Inc.	BZK	Class II	1998-12-09
K981737	K-Defib/pace Adult Electrode Model Number Kdp-60	Katecho LLC	MKJ	Class III	1998-12-09
K980378	Melodie Infusion Pump	Compagnie de Developpement Aguettant	FRN	Class II	1998-12-09
K984157	Modification to Wilson-Cook Lung Biopsy Needle	Wilson-Cook Medical Inc.	EOQ	Class II	1998-12-08
K984105	Elecsys Troponin T Stat Test	Boehringer Mannheim Corp.	MMI	Class II	1998-12-08
K984023	Maxview Diagnostic Workstation	Dynamic Healthcare Technologies, Inc.	LLZ	Class II	1998-12-08
K983804	The Aptus (Automated) Application of the Ebv-Ea Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for	Zeus Scientific LLC	LSE	Class I	1998-12-08
K983724	Orca-Dx Bone Densitometer	Lunar Corp.	KGI	Class II	1998-12-08
K983564	Prodigy Total Body Software	Lunar Corp.	KGI	Class II	1998-12-08
K983459	Pulsed Oxygen Conserving Device, Pocd	Medical Electronic Devices, Inc.	NFB	Class II	1998-12-08
K982303	Precision Pcx Point of Care Management System , Qc Manager Data Manager System, Precision G Plus Blood Glucose Test St	Medisense, Inc.	CGA	Class II	1998-12-08