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 2376 of 3531

510(k) clearances, page 2376 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K921596	Sharplan C02 Ultraswift Vaporization Endpiece	Sharplan Lasers, Inc.	GEX	Class II	1992-05-13
K921013	Syva Emit II Methaqualone Assay	Syva Co.	KXS	Class II	1992-05-13
K920812	Fairbanks Baby Scale	Fairbanks Scales, Inc.	FRW	Class I	1992-05-13
K920240	Solumbra Sun Protective Clothing	Wetmore Assoc., Inc.	MIW		1992-05-13
K920013	Uni-Dose Syringe Pump	Electrochemical Drug Delivery, Inc.	FRN	Class II	1992-05-13
K915874	Basket Litter Carrier	Bradco Med, Ltd.	FPP	Class I	1992-05-13
K914966	Tsrh Central Post Hooks	Sofamor Danek Mfg., Inc.	KWP	Class II	1992-05-12
K910616	Lb-2000 Cranial Electrotherapy Stimulator	Life Balance Intl., Inc.	QJQ	Class II	1992-05-12
K903014	Alpha-Stim Cs	Electromedical Products, Inc.	QJQ	Class II	1992-05-12
K921535	Suoena Affinity (Tm) Model #802	MEDLINE INDUSTRIES, LP - Northfield	KCZ	Class I	1992-05-11
K921439	Bisco Core Paste	Bisco, Inc.	EBF	Class II	1992-05-11
K921369	Biomedical Horizons Model 1001	Biomedical Horizons, Inc.	KNN	Class I	1992-05-11
K921331	Cambridge Pc/gxt Stress Test System	Health Watch, Inc.	DPS	Class II	1992-05-11
K921055	Kendall Curity Kids Pediatric Drainage Adapter	Kendall Healthcare Products Co. Div.Of Tyco Health	KNY	Class II	1992-05-11
K920700	Seamless Latex Patient Exam Gloves	Digitcare Corp.	LYY	Class I	1992-05-11
K920600	Dab Detection Kit	Ventana Medical Systems Inc	DEY	Class II	1992-05-11
K920517	Minor Laceration Tray W/ Instrument, Sterile, Disp	Trinity Laboratories, Inc.	KKX	Class II	1992-05-11
K920492	High Vac	Hygoplastic, Inc.	DYN	Class I	1992-05-11
K920409	Dacomed Battery Operated Vacuum Erection Device	Dacomed Corp.	LKY	Class II	1992-05-11
K920280	Suture Removal Kit, Sterile, Disposable	Trinity Laboratories, Inc.	MCZ	Class I	1992-05-11
K915819	Brainscan Workstation	Brainlab Medizinische Computersysteme GmbH	HAW	Class II	1992-05-11
K915411	Dade Immunoadsorbed Factor IX Deficient Plasma	Baxter Diagnostics, Inc.	GJT	Class II	1992-05-11
K915323	The Beltone Audio Scout	Beltone Electronics Corp.	EWO	Class II	1992-05-11
K921656	Lifesound Ite (Lsi-I)w/ Triton 3004I Programmable	Siemens Hearing Instruments, Inc.	ESD	Class I	1992-05-08
K921441	Interferential Stimulator Model Inf 4150/A	BioMedical Life Systems Inc.	LIH	Class II	1992-05-08
K921420	Azithromycin, 15 Mcg, Sensi Disc	BD Becton Dickinson Vacutainer Systems Preanalytic	JTN	Class II	1992-05-08
K920773	Durafuse Infusion Pump	BD Becton Dickinson Vacutainer Systems Preanalytic	FRN	Class II	1992-05-08
K920582	180 Tip, 1/A Handpiece .3Mm End Opening for Opht.	Site Microsurgical Systems, Inc.	HQE	Class II	1992-05-08
K920566	Aec Detection Kit	Ventana Medical Systems Inc	DEY	Class II	1992-05-08
K915477	Sterilization Bag, Polyester/wrap	Cgs Supplies Corp.	KCT	Class II	1992-05-08
K915230	H Wave Muscle Stimulator	Electronic Waveform Laboratory, Inc.	IPF	Class II	1992-05-08
K915109	Rapid Add Site Double Lumen I.v.extension Set	Ballard Medical Products	FPA	Class II	1992-05-08
K914887	Esophageal Stethoscope W/temp Sensor/gastric Suct	Mallinckrodt Medical	FRQ	Class II	1992-05-08
K914577	Rhythmscan Precision 6000	Precision Health Care Systems, Inc.	DQK	Class II	1992-05-08
K914180	Deseret(r) Flow Restriction Valve	Becton Dickinson Vascular Access, Inc.	FOZ	Class II	1992-05-08
K910925	Disinfection with the Cox Dry Heat Sterilizer	Cox Sterile Products, Inc.	KMH	Class II	1992-05-08
K921488	Aspirating Endo Ocular Probe W/illumination	Surgical Technologies, Inc.	HMX	Class I	1992-05-07
K921212	Mirco Elisa Hpl Test Kit	Bio Clinic Co.	JHI	Class II	1992-05-07
K921211	Now Pregnancy Test Kit	Bio Clinic Co.	JHI	Class II	1992-05-07
K921016	Synermed Alt/gpt Reagent Kit	Synermed, Inc.	CKA	Class I	1992-05-07
K920926	Kemtrol Serum Control-Abnormal	Helena Laboratories, Corp.	JJY	Class I	1992-05-07
K920571	Trial Lens Set	R.H. Burton Co.	HPC	Class I	1992-05-07
K920109	Imx Insulin	Abbott Medical	CFP	Class I	1992-05-07
K921582	Flowers Medial Malar Implant	Implantech Associates Inc	LZK	Class II	1992-05-06
K921581	Chin Wafer	Implantech Associates Inc	FWP	Class II	1992-05-06
K921580	Brink Pre-Maxillary Implant	Implantech Associates Inc	FZE	Class II	1992-05-06
K921472	M4-Rt Transport Medium, (M4 Modification)	Microtest	JSM	Class I	1992-05-06
K921282	Maxaquin	Difco Laboratories, Inc.	JTN	Class II	1992-05-06
K921091	Cholangiolapcath(tm)	BD Becton Dickinson Vacutainer Systems Preanalytic	GBZ	Class I	1992-05-06
K921029	Dobbhoff Bipolar Adapter	Biosearch Medical Products, Inc.	KNS	Class II	1992-05-06