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 1842 of 3531

510(k) clearances, page 1842 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K974356	Surgeon's Gloves	American Health Products, Inc.	KGO	Class I	1998-01-29
K974288	Zerowet Splashield	Zerowet, Inc.	KYZ	Class I	1998-01-29
K974283	Pq 1	Ultradent Products Inc.	KLE	Class II	1998-01-29
K974282	Vitalescence	Ultradent Products Inc.	EBF	Class II	1998-01-29
K974231	Position Penta, Position Penta Quick	Espe GmbH & Co. KG.	ELW	Class II	1998-01-29
K974130	Visishare Imaging System and/ or Software, Visishare System and/ or Software	Dejarnette Research Systems	LMD	Class I	1998-01-29
K974121	Lubricated Baggy Tactylon Condom	Sensicon Corp.	MOL	Class II	1998-01-29
K974112	Vacudap, Model 2000, 2001	Victoreen, Inc.	KPR	Class II	1998-01-29
K973981	Safepass Sterilization Pouch	Adroit Medical Systems, Inc.	KCT	Class II	1998-01-29
K973792	Easysafe Retracting Needle Syringe	Saf-T-Med, Inc.	MEG	Class II	1998-01-29
K973267	Ttm5000 Telephonic EKG Monitor	Hds Medical, Inc.	DXH	Class II	1998-01-29
K973106	Golemb Disposable Bag Mask Resuscitator	Allied Medical LLC	BTM	Class II	1998-01-29
K973104	Norland Model Pdexa Bone Densitometer	Norland Corp.	KGI	Class II	1998-01-29
K972935	Super-Dent Intermediate Restorative Material	S.S. White Mfg., Ltd.	EMA	Class II	1998-01-29
K971670	3 Channel Digital Ambulatory ECG Recorder	Galix Biomedical Instrumentation, Inc.	DSH	Class II	1998-01-29
K971369	Browne Mvi Steam Indicator	Sybron Dental Specialties, Inc.	JOJ	Class II	1998-01-29
K980135	Qualicheck5+ Models S7730, S7740, S7750, S7760	Radiometer America, Inc	JJS	Class I	1998-01-28
K980055	Careside Globulin	Exigent Diagnostics, Inc.	JGE	Class I	1998-01-28
K974762	Stat Tracks	Awareness Technology, Inc.	JJQ	Class I	1998-01-28
K974552	Diamedix Is-Measles Igg Test System	Diamedix Corp.	LJB	Class I	1998-01-28
K974193	Narkomed Ultrasonic Flow Sensor	Draeger, Inc.	BSZ	Class II	1998-01-28
K974146	Paracentesis Catheter Device	Medtronic, Inc.	GCB	Class I	1998-01-28
K974142	Hm-Ruby	American Lasers, Inc.	GEX	Class II	1998-01-28
K974139	Lquet Cannula/trocar System	Lifequest Endoscopic Technologies, Inc.	GCJ	Class II	1998-01-28
K974119	Disposable Needle Electrode (Alm), Disposable Needle Electrode (Dlm)	Jack'S Electrodes	GXZ	Class II	1998-01-28
K974098	Pubouurethral Sling	Ethicon, Inc	OTN	Class II	1998-01-28
K974095	Foundation Porous Coated Flared Rim Shell	Encore Orthopedics, Inc.	LPH	Class II	1998-01-28
K974093	Foundation Porous Coated Hemispherical Shell	Encore Orthopedics, Inc.	LPH	Class II	1998-01-28
K973119	Foundation Porous Acetabular System	Encore Orthopedics, Inc.	LPH	Class II	1998-01-28
K972989	Stc Methamphetamine Micro-Plate Eia	OraSure Technologies, Inc.	DKZ	Class II	1998-01-28
K972605	Ems Nasal CPAP Mask	Engineered Medical Systems, LLC	BZD	Class II	1998-01-28
K971829	Mis Electrosurgical Electrode	E-Tek, Inc.	GEI	Class II	1998-01-28
K971636	Rifampicin Antimicrobial Susceptibility Test Disc	Oxoid, Ltd.	JTN	Class II	1998-01-28
K970333	Bactec Myco/f Lytic Culture Vials	Becton Dickinson Microbiology Systems	MDB	Class I	1998-01-28
K974861	Non-Prescription Sunglasses	Wenzhou Hindar Optical Co., Ltd.	HQY	Class I	1998-01-27
K974820	Breezy Series	Sunrise Medical, Inc.	IOR	Class I	1998-01-27
K974621	Percupump II with Eda	E-Z-EM, Inc	DSB	Class II	1998-01-27
K974613	Virotrol III	Blackhawk Biosystems, Inc.	JJY	Class I	1998-01-27
K974419	Rusch Simplastic Councill Tip Catheter	Rusch, Inc.	EZL	Class II	1998-01-27
K974308	Medrad 1.5T Peripheral Vascular Array	Medrad, Inc.	MOS	Class II	1998-01-27
K974255	Cd-R Station and Vrs-2000	Electromed Intl., Ltd.	LMD	Class I	1998-01-27
K974224	Endolymphatic Sac to Mastoid T-Shunt	Exmoor Plastics Limited	ESZ	Class II	1998-01-27
K974134	X-Sight Digital Imaging System	Stallion Technologies, Inc.	LLZ	Class II	1998-01-27
K974085	Cobe Oxygenator Products	LivaNova USA, Inc.	DTZ	Class II	1998-01-27
K973506	Activator II	Activator Methods, Inc.	LXM	Unclassified	1998-01-27
K973037	N.i.t., Inc. Radionuclide Seed Applicator, Model Sa-1000	Avid N.I.T., Inc.	IWJ	Class I	1998-01-27
K965106	Elc 35-Up Model Number 116015 and Elc 54-Up Model Number 115606	BIOTRONIK AG	DTB	Class III	1998-01-27
K963903	Biospectrometer-Nb Oximeter Iiii	Hutchinson Technology, Inc.	MUD	Class II	1998-01-27
K974821	Bluetest(r) Pregnancy Test, Rapidvue(r) Pregnancy Test	Ortho-Clinical Diagnostics, Inc.	LCX	Class II	1998-01-26
K974733	Boehringer Mannheim Direct Ldl - Cholesterol	Boehringer Mannheim Corp.	LBR	Class I	1998-01-26