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 2700 of 3530

510(k) clearances, page 2700 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K883126	Brevet Dental Instruments	Brevet Inc.	EKJ	Class I	1988-10-05
K882966	Model 320 Fetal/maternal Telemetry System	GE Medical Systems Information Technologies, Inc.	HGM	Class II	1988-10-05
K882904	Tdk Electrode Mel-20-1, Mel-20-3, Mel-20-5	Tdk Corp.	DRX	Class II	1988-10-05
K882567	Skincote	Dynarex Corp.	FRO	Unclassified	1988-10-05
K882235	Poly-Tac	Cardiovascular Group, Inc.	LDD	Class II	1988-10-05
K884079	Model Cbx Epilator	R. A. Fischer Co. Corp.	KCW	Class I	1988-10-04
K883823	Bernsco Electrosurgical Shield	Bernsco Surgical Supply, Inc.	GEI	Class II	1988-10-04
K883774	Bernsco Needle Adapter	Bernsco Surgical Supply, Inc.	GEI	Class II	1988-10-04
K883680	Medalist Examination Table	Hamilton Industries, Inc.	LGX	Class I	1988-10-04
K883415	Vasculon 2 Intravenous Cannula	GE Healthcare	FOZ	Class II	1988-10-04
K883313	Pmt Vascular Catheter Model Number 3621-1	PMT Corp.	LJS	Class II	1988-10-04
K883164	Instaject II	Pavel Jordan & Associates, Inc.	KZH	Class II	1988-10-04
K883009	Non-Coring Needles	Quinton, Inc.	FMI	Class II	1988-10-04
K882595	Medical Gloves Sterile Latex Surgeons Digiform	Marathon Management Co.	KGO	Class I	1988-10-04
K881966	Electrophysiology Electrode Cath. W/silver/silver	C.R. Bard Inc	DRF	Class II	1988-10-04
K881805	Tu Stopcock	Tulan Corp. C/O Richard Hamer Assoc.	FMG	Class II	1988-10-04
K881415	Omron Digital Fever Thermometer Model Mc-3	Omron Electronics, Inc.	FLL	Class II	1988-10-04
K883929	Tanning Bed	Dallas Tan, Inc.	FTC	Class II	1988-10-03
K883828	Cone Masks, Various Types of Surgical Cone Masks	Greene International Corp.	FXX	Class II	1988-10-03
K883741	Qtest Pregnancy Test Control	Ortho-Clinical Diagnostics, Inc.	JJX	Class I	1988-10-03
K883721	Female Continence Device	Cook Ob/Gyn	HHW	Class II	1988-10-03
K883582	Varidyne Model 250 Suction Drainage System	Surgidyne, Inc.	BTA	Class II	1988-10-03
K882115	A-Sorb	Howard Medical Co.	NAB	Class I	1988-10-03
K881627	Delfia(tm) Neonatal Htsh Kit	Pharmacia, Inc.	JLW	Class II	1988-10-03
K883966	Hare Cold Pack	Dyna Industries, Inc.	IMD	Class I	1988-09-30
K883951	Medium 199 W/ebss (Catalog No. 200-2037)	J R Scientific	KIT	Class I	1988-09-30
K883869	Dermtrode	World Precision Instruments, LLC	GYA	Class I	1988-09-30
K883693	Resuscitation Bag Exhalation Filter	Intertech Resources, Inc.	CAH	Class II	1988-09-30
K883681	Das Sport Pump(tm)	D.A. Schulman, Inc.	ILO	Class II	1988-09-30
K883663	Ats Blood Recovery Bag	Atrium Medical Corporation	CAC	Class II	1988-09-30
K883607	Peel-Away Introducer for Ventricular Catheter	Cerenovus, Inc.	GYK	Class I	1988-09-30
K883593	#400 Brook Airway & #900 Professional Brook Airway	Microtek Medical LLC	CAE	Class I	1988-09-30
K883576	Horizon Orthopedic Pin Protector	Horizon Medical, Inc.	LYT	Class II	1988-09-30
K883522	Amerimed Ultrasonic Surgical Aspiration Kit	Amerimed US Corp.	LBK	Unclassified	1988-09-30
K883309	Multi-Care Chair	Mid-Canada Medical	INM	Class I	1988-09-30
K883235	Rapidtest-Hcg (Tm)	Synbiotics Corp.	DHA	Class II	1988-09-30
K883223	Check-Mm	Intl. Immunoassay Laboratories, Inc.	JHS	Class II	1988-09-30
K883222	Isofor-Mm (Tm)	Intl. Immunoassay Laboratories, Inc.	JHW	Class II	1988-09-30
K883127	Multi-Channel Strain-Gage Amplifier & Power Supply	Advanced Mechanical Technology Inc	KHX	Class I	1988-09-30
K883124	Amerlite Free Thyroid Control Sera Lan.4002	Amersham Corp.	JJY	Class I	1988-09-30
K883118	On the Spot Candidasure	Medi-Tech, Inc.	LRF	Class II	1988-09-30
K883067	Modified Sl-Series Linear Accelerators	Philips North America LLC	IYE	Class II	1988-09-30
K882967	Bone Fixation Wire	Baxter Healthcare Corporation	JDQ	Class II	1988-09-30
K882908	Slt Cl60 Contact Laser System, Cutting & Coagula.	Surgical Laser Technologies, Inc.	HQF	Class II	1988-09-30
K882888	Multiday, Models 8300 and 8310	Medical Devices Inc.	GXY	Class II	1988-09-30
K882877	Jms Cervical Traction Device/halo Device	Jerome Medical	JEC	Class II	1988-09-30
K882799	Helena Colocare	Helena Laboratories, Corp.	KHE	Class II	1988-09-30
K882764	Bear Evc-100 Controller	Bear Medical Systems, Inc.	CBK	Class II	1988-09-30
K882582	Sterile Inhalation Water Transfer Set	Intertech Resources, Inc.	BTT	Class II	1988-09-30
K882211	Uriscreen	Diatech Diagnostica, Ltd.	JXA	Class I	1988-09-30