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 2026-11-09, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,227 of the 176,624 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	2,827

176,624 records, page 1728 of 3533

510(k) clearances, page 1728 of 3533
K number	Device	Applicant	Product code	Class	Decision date
K991904	Modification of Jms Needles and Jms Syringes	Jms Co., Ltd.	FMI	Class II	1999-08-31
K991778	Latex Examination Gloves Polymer Coated (Powder-Free)	Seltom Pacific Sdn. Bhd.	LYY	Class I	1999-08-31
K991777	Latex Examination Gloves Powder-Free with Protein Labeling Claim (50 Micrograms or Less Total Extractable Protein)	Seltom Pacific Sdn. Bhd.	LYY	Class I	1999-08-31
K990536	O.b. Tampon	Personal Products Co.	HEB	Class II	1999-08-31
K990487	Equinox Occlusion Balloon System	Medtronic, Inc.	MJN	Class II	1999-08-31
K990478	Card Guard, Model Cg-6550	Card Guard Scientific Survival, Ltd.	DXH	Class II	1999-08-31
K992598	Tof-Watch Sx	bioMerieux, Inc.	KOI	Class II	1999-08-30
K992596	Tof-Watch S	bioMerieux, Inc.	KOI	Class II	1999-08-30
K992483	Medifix Inc.	Medifix, Inc.	FAJ	Class II	1999-08-30
K992463	Synthetic Powder-Free Vinyl Patient Examination Gloves	Shijiazhuang Dilly Plastics Products Co., Ltd.	LYZ	Class I	1999-08-30
K992430	Cardioimmune Cardiac Marker Control Levels 1,2, and 3	Medical Analysis Systems, Inc.	JJT	Class I	1999-08-30
K992357	Easy-Cure (Curing and Whitening Light)	Ics of North America, Inc.	EBZ	Class II	1999-08-30
K992243	Virgo Beta 2 Glycoprotein Igm Antibody Kit	Hemagen Diagnostics, Inc.	MSV	Class II	1999-08-30
K992241	Virgo B2 Glycoprotein I Iga Antibody Kit	Hemagen Diagnostics, Inc.	MSV	Class II	1999-08-30
K992224	Virgo Beta 2 Glycoprotein Igg Antibody Kit	Hemagen Diagnostics, Inc.	MSV	Class II	1999-08-30
K992223	Health-Plus, Sanitex, Reliance Powder-Free Nitrile Examination Glove	Pamitex Industries Sdn Bhd	LZA	Class I	1999-08-30
K992164	Telemedicine 2000	Card Guard Scientific Survival, Ltd.	DXH	Class II	1999-08-30
K992162	Safeskin Purple Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic Drugs Labeling Claim	Safeskin Corp.	LZC	Class I	1999-08-30
K992076	Pasco Mic and Mic/id Panels (Cefuroxime)	Pasco Laboratories, Inc.	JTN	Class II	1999-08-30
K992066	Revolution Tx/i Digital Radiographic Table System	GE Healthcare	KPR	Class II	1999-08-30
K992059	Pasco Mic and Mic/id Panels	Pasco Laboratories, Inc.	JWY	Class II	1999-08-30
K991851	Renaclear Dialyzer Cleaning System	Medivators Inc	LIF	Class II	1999-08-30
K991437	Wells Johnson Infusion System, Model 20-6000-00	Wells Johnson Co.	FRN	Class II	1999-08-30
K991237	Xplan-2 with Head and Neck Localizer, Model Hnl	Radionics, Inc.	MUJ	Class II	1999-08-30
K990510	Jms Apheresis Needle	JMS Co., Ltd.	FIE	Class II	1999-08-30
K990470	Jms a. V. Fistula Needle Set	JMS Co., Ltd.	FIE	Class II	1999-08-30
K990310	Charter Medical, Ltd Mp 450 (40 Micron Filter)	Charter Medical, LLC	CAK	Class II	1999-08-30
K990271	Endosonics Trak Back Device	Endosonics Corp.	DQX	Class II	1999-08-30
K992567	Anatomical Bankart Tack, Model 523520A	Bionx Implants, Inc.	MAI	Class II	1999-08-27
K992516	Dyract Seal Compomer Pit & Fissure Sealant	Dentsply Intl.	EBC	Class II	1999-08-27
K992485	Monopolar Electrodes and Cables	Us Endo, Inc.	GEI	Class II	1999-08-27
K992457	Snn System with Olivier Double Chuck Support Arm Option	Surgical Navigation Specialists, Inc.	HAW	Class II	1999-08-27
K992304	Navigus Trajectory Guide, Model Tg-Xxxx	Image-Guided Neurologics, Inc.	HAW	Class II	1999-08-27
K992283	Artisan Acquisition System for EEG and Polysomnography	Airsep Corp.	OLV	Class II	1999-08-27
K992236	Lysta Lc Compacta Curing Light, Models Lc 2500 Compacta, Lc 4000 Compacta, Lc 6000 Compacta & Lc 8000 Compatca	Lysta A/S	EBZ	Class II	1999-08-27
K992198	Urethane Picc Line Model Upics-	Cook Inc.	FOZ	Class II	1999-08-27
K992071	Transvaginal Ultrasound Probe Holder Device	Ron-Tech Medical, Ltd.	HDC	Class II	1999-08-27
K992067	Belleglaze	Kerr Dental Materials Center	EBD	Class II	1999-08-27
K992024	Super Porcelain Ti-22	Noritake Co., Inc.	EIH	Class II	1999-08-27
K991995	Softchrome Tints, Transparent Tinted Soft Contact Lens	Softchrome, Inc.	MZD	Class II	1999-08-27
K991989	Mitaka Point Setter	Mitaka USA, Inc.	GWG	Class II	1999-08-27
K991729	Ferris Polyostomy Sterile Wound Dressing	Ferris Mfg. Corp.	KMF	Class I	1999-08-27
K991726	Binax Nowr Streptococcus Pneumoniae Urinary Antigen Test (22 Test Kit),(12 Test Kit), Binax Nowr Streptococcus Pneumoni	Binax, Inc.	GTZ	Class I	1999-08-27
K991508	Acumaster Brand Acupuncture Needle	Helio Medical Supplies, Inc.	MQX	Class II	1999-08-27
K991507	Kangnian Brand Acupuncture Needle	Helio Medical Supplies, Inc.	MQX	Class II	1999-08-27
K991198	Dyna-Lok Plus Spinal System	Sofamor Danek USA,Inc.	KWP	Class II	1999-08-27
K991089	Synthes Cervifix System	Synthes GmbH	KWP	Class II	1999-08-27
K991055	Osteonics Spinal System- Rod/ Plate System	Howmedica Osteonics Corp	MNH	Class II	1999-08-27
K990903	Lyra Series Surgical System (Sl Seriesq-Switched Nd:yag Configuration)	Laserscope	GEX	Class II	1999-08-27
K990785	Trocar & Trocar Sleeves, Laparoscopes, Laparoscopic Forceps, & Laparoscopic Instruments	Jakoubek Medizintechnik GmbH	GCJ	Class II	1999-08-27