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 2546 of 3530

510(k) clearances, page 2546 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K901794	Air Cushioned Auto Wheelchair Lift Acl-200/Ag-Z2	Metal Dynamics Corp.	ING	Class II	1990-05-07
K901764	Inamed Convertible Drain System	Inamed Development Co.	GCY	Class I	1990-05-07
K901761	Sterile Suction Tubing Set	Acacia Laboratories, Inc.	BYY	Class II	1990-05-07
K901742	Inamed Small Drain System	Inamed Development Co.	GCY	Class I	1990-05-07
K901620	Multipurpose Coil & 3Mm Slice Thickness on the MRI	Instrumentarium Imaging, Inc.	LNH	Class II	1990-05-07
K901602	Version 4.3 Application Software for Use W/rx-4000	Resonex, Inc.	LNH	Class II	1990-05-07
K901405	Digiformer Hr Dfp-50A	Toshiba America Medical Systems, In.C	JAA	Class II	1990-05-07
K901228	Multi-Strip	Bellhouse Medical, Inc.	FKX	Class II	1990-05-07
K901087	Modified Profile II Acetabular Cup Prosthesis	Depuy, Inc.	JDI	Class II	1990-05-07
K901053	Mirror Shield	Pulpdent Corporation	EKJ	Class I	1990-05-07
K900988	Amcath Suction-Irrigation Tube	Intl. Medical, Inc.	HET	Class II	1990-05-07
K900878	Ott Insufflation Filter Tubing	Gynescope Corp.	HIF	Class II	1990-05-07
K900765	Steerocath(tm)	Ep Technologies, Inc.	DRF	Class II	1990-05-07
K900651	Ts-1800 Medication Transfer Spike	The Medi-Dose Group	FPA	Class II	1990-05-07
K900633	Disp. Electrosurgery Pencil, Hand Control	Medical/Surgical Specialties, Ltd.	GEI	Class II	1990-05-07
K900388	Modified Sterilization of Drills, Burrs, Trephines	Midas Rex Pneumatic Tools, Inc.	HBE	Class II	1990-05-07
K900356	Thermoaire Splint (Tm) (Tas)	Life Enhancement Technologies, LLC	ILO	Class II	1990-05-07
K900342	Unity Dental Cement	Whaledent Intl. Div. Ipco	EMA	Class II	1990-05-07
K900194	Mthf-9S Mobil C-Arm Image Intensifier Unit	Imt America, Inc.	OXO	Class II	1990-05-07
K900135	Cu-75 Visible Light-Curing Unit	Kab Gloves Unltd.	EBZ	Class II	1990-05-07
K896946	Coated Novafil, Polybutester, Mesh	American Cyanamid Co.	FTM	Class II	1990-05-07
K896755	Aloka 680 Diagnostic Ultrasound Scanning System	GE Medical Systems Information Technologies, Inc.	IYO	Class II	1990-05-07
K896708	Perlink Cassette, Kiran Cassette	Perlink USA, Inc.	IXA	Class II	1990-05-07
K896530	Fermit Temporary Material	Ivoclar North America, Inc.	EBF	Class II	1990-05-07
K895358	Thermo-5000	Medtronix Ltd., Inc.	LHQ	Class I	1990-05-07
K894828	Hpi Ortho Surgeons' Glove	Tillotson Rubber Co., Inc.	KGO	Class I	1990-05-07
K893215	Vitajet(insulin Jet Injection Device)	Vitajet Industriae Comercioltda.	KZE	Class II	1990-05-07
K901603	Modified Porges Spec 5* Suprapubic Catheter	Bivona Medical Technologies	KOB	Class II	1990-05-04
K901318	Stayerec System(tm)	Osbon Medical Systems, Ltd.	LKY	Class II	1990-05-04
K901229	Chem 1 Clinical Analyzer (Method Urine Creatinine)	Technicon Instruments Corp.	CGX	Class II	1990-05-04
K901223	Vacuum Erection Device (Ved)	Mission Pharmacal Company	LKY	Class II	1990-05-04
K901011	Biosign Hcg-One Step Pregnancy Test	Princeton Biomedix	JHI	Class II	1990-05-04
K900832	Modified Depuy Acetabular Cup System* Hip Aceta.	Depuy, Inc.	JDI	Class II	1990-05-04
K900774	Dacomed Negative Pressure Erection Device	Dacomed Corp.	LKY	Class II	1990-05-04
K900767	B-300 Combination Switching Disposable Handpiece	Beacon Laboratories, Inc.	GEI	Class II	1990-05-04
K900726	Microtek Medical's Blood Collection Kit	Microbio-Medics, Inc.	JKA	Class II	1990-05-04
K900630	Models 4000/4900/6000/8000/8900, Luxas&1700 Nd:yag	Heraeus Lasersonics, Inc.	GEX	Class II	1990-05-04
K896288	Flexilog 1010 Ambulatory Ph Monitoring System	Oakfield Instruments, Ltd.	FFT	Class I	1990-05-04
K893039	Condom (Rubber) Contraceptive	Chinteik Hygiene Products Co., Ltd.	HIS	Class II	1990-05-04
K892503	Nuffield Total Knee	Mizuho Orthopedic Systems Inc	JWH	Class II	1990-05-04
K901859	Coat-a-Count Total Ige Irma, Catalog #Ikie1, Ikie2	Siemens Healthcare Diagnostics Inc.	JHR	Class II	1990-05-03
K901834	Instant Ice Pack	Impact Packaging Corp.	IMD	Class I	1990-05-03
K901707	Fortress Commuter Ft (Folding Transport)	Fortress, Inc.	ITI	Class II	1990-05-03
K901468	Children's Sunglasses	M. & S. Shillman, Inc.	HQY	Class I	1990-05-03
K901008	Hexascan Handpiece	Lihtan Technologies, Inc.	GEX	Class II	1990-05-03
K900984	Modified Unipolar Implant. Pacing Leads W/is-1	Medtronic, Inc.	DTB	Class III	1990-05-03
K900903	Kopans Hookwire Lesion Localization Needle	Milex Products, Inc.	GDF	Class I	1990-05-03
K900812	Medicam Arthroscope Systems	Kirschner Medical Corp.	HRX	Class II	1990-05-03
K900751	Heraeus Lasersonics CO2 Waveguide Delivery System	Heraeus Lasersonics, Inc.	GEX	Class II	1990-05-03
K900566	Richard-Allan Vessel Loops	Richard-Allan Medical Ind., Inc.	KDC	Class I	1990-05-03