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 1397 of 3531

510(k) clearances, page 1397 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K040365	Color Coronis 2Mp Medical Flat Panel Display System	Barco N.V.	LLZ	Class II	2004-04-28
K040340	K-Y Brand Warming Ultragel Personal Lubricant	Personal Products Company, Div. of Mcneil-Ppc, Inc.	NUC	Class II	2004-04-28
K031664	Elements Obturation Unit	Sybron Endo/Analytic	EKR	Class I	2004-04-28
K031457	Endomat Lc Pump, Model 20 3303 20	Karl Storz Endoscopy-America, Inc.	OCX	Class II	2004-04-28
K040984	Vision Sciences Model ENT-2000V Flexible Nasopharyngo-Laryngoscope	Cogentix Medical, Inc.	EOB	Class II	2004-04-27
K040764	Stryker T4 Hytrel Zipper Toga	Stryker Corp.	FYA	Class II	2004-04-27
K040702	Synthetic (Yellow) Vinyl Patient Examination Gloves - Powder Free	Grand Work Plastic Products Co., Ltd.	LYZ	Class I	2004-04-27
K040632	Snuggle Warm 4000 Convective Warming System, Model Sw4000	Abbott Medical	DWJ	Class II	2004-04-27
K040546	Image-Arena and Research-Arena Applications	TOMTEC Imaging Systems GmbH	LLZ	Class II	2004-04-27
K040489	Aquadex System 100, Model A1100	Chf Solutions, Inc.	KDI	Class II	2004-04-27
K040440	Http System (Http 2001 Controller and Http Warm Me Blankets)	Http Hypothermia Therapy	DWJ	Class II	2004-04-27
K040193	Model Gst-1	Medical Equipment Device Specialists	GZJ	Class II	2004-04-27
K040185	Durex Studded/ribbed Lubricated Latex Condom	Ssl Americas, Inc.	HIS	Class II	2004-04-27
K040067	Clirpath Excimer Laser Catheter	Spectranetics Corp.	PDU	Class II	2004-04-27
K040054	Back in Action Compression & Support with Magnets for the Lower Back, Knee and Ankle	Theodore Barash	FQM	Class I	2004-04-27
K033905	Protegrity Steile Latex Surgical Gloves with Coating	Cardinalhealth	KGO	Class I	2004-04-27
K033611	Calcigen -Nap Bone Void Filler	Zimmer GmbH	MQV	Class II	2004-04-27
K033505	Renaclean Sh Dialyzer Cleaning System	Medivators Inc	LIF	Class II	2004-04-27
K033171	Nsi Hexed and Non-Hexed Implant System and Immediate Loading	Northern Implants, LLC	DZE	Class II	2004-04-27
K033163	Caution Condoms	Richard van Haussen America, Inc.	LTZ	Class II	2004-04-27
K033098	Osteogen Sbrg	Impladent, Ltd.	LYC	Class II	2004-04-27
K033085	Portaclamp	Cardio Life Research, S.A.	DXC	Class II	2004-04-27
K040846	Sensititre Haemophilus/streptococcus Pneumoniae (Hp) Mic Plates	Trek Diagnostic Systems, Ltd.	JWY	Class II	2004-04-26
K040605	Dymedix Reusable Respiratory Effort Belt Sensor, Model 6015 and Dymedix Reusable Limb Movement Sensor, Model 3100	Dymedix, Inc.	BZQ	Class II	2004-04-26
K040287	Vigilance Continuous Cardiac Output/oximetry/continuous End Diastolic Volume (Cc0/svo2/cedv) Monitor	Edwards Lifesciences LLC	DXG	Class II	2004-04-26
K034063	Multiblast Medium	FUJIFILM Biosciences Inc.	MQL	Class II	2004-04-26
K033498	Narkomed 6400, Model Nm6400	Draeger, Inc.	BSZ	Class II	2004-04-26
K033114	Ketochecks	Neo Diagnostics, Inc.	JIN	Class I	2004-04-26
K030071	Servo Guard, Model 64 81 290 Eh88e	Maquet Cardiovascular Us Sales, LLC	CAH	Class II	2004-04-26
K022256	Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and Green	Tucker & Associates	FXX	Class II	2004-04-26
K020700	Pmh 5000 Heated Humidifier for Respiratory Therapy	Pegasus Research Corp.	BTT	Class II	2004-04-26
K040937	Tem 3000 Head Coil	Mr Instruments, Inc.	MOS	Class II	2004-04-23
K040884	Lorad Digital Spot Mammography System	Hologic, Inc.	IZH	Class II	2004-04-23
K040852	Preview Treatment Planning Software	Medical Media Systems	LLZ	Class II	2004-04-23
K040821	Coalescent Surgical U-Clip and Accessories	Coalescent Surgical	FZP	Class II	2004-04-23
K040775	Lifepak 12	Physio Control, Inc.	MKJ	Class III	2004-04-23
K040771	Modification to Outback Catheter	Lumend, Inc.	DQY	Class II	2004-04-23
K040727	Cryo 5	Zimmer Elektromedizin GmbH	GEX	Class II	2004-04-23
K040468	Cedara I-Softview and Cedara I-Readmammo	Cedara Software Corp.	LLZ	Class II	2004-04-23
K040194	Compumedics Summit Ip	Compumedics USA, Inc.	MNR	Class II	2004-04-23
K033860	Autokit Total Ketone Bodies Kit (Serum) and Wako Ketone Body Calibrator	FUJIFILM Healthcare Americas Corporation	JIT	Class II	2004-04-23
K033153	Dicom Theater	Ferguson Medical	LLZ	Class II	2004-04-23
K031661	5M Medical Flat Panel Display, Me511l	Totoku Electric Co., Ltd.	LLZ	Class II	2004-04-23
K040796	Accu-Chek Go System	Roche Diagnostics GmbH	LFR	Class II	2004-04-22
K040770	Vanguard Patella Components	Biomet Manufacturing Corp	JWH	Class II	2004-04-22
K040743	Modification to Datex-Ohmeda S/5 Avance Anesthesia System	GE Healthcare	BSZ	Class II	2004-04-22
K040607	Modification to Powderfree Colored and Flavored Chloroprene Patient Examination Gloves	PT. Medisafe Technologies	LZA	Class I	2004-04-22
K040584	Nmx-1000	Neomedix Corp.	GEI	Class II	2004-04-22
K040567	Gc Initial Mc, Al and Lf	GC America Inc.	EIH	Class II	2004-04-22
K040545	Otter Safety Syringe	Otter (China) Technology Co., Ltd.	MEG	Class II	2004-04-22