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 2026-11-02, 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 2395 of 3531

510(k) clearances, page 2395 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K915171	Lopez Valve Tm II	Abbott Medical	KNT	Class II	1992-02-07
K915159	Pediatric Multi-Function Electrodes	Zmi Corp.	DRF	Class II	1992-02-07
K914763	Dermacare Synthetic Medical Glove	BD Becton Dickinson Vacutainer Systems Preanalytic	LYZ	Class I	1992-02-07
K914601	Suction Connecting Tubing	Bemis Mfg. Co.	GCX	Class II	1992-02-07
K913993	Medtronic Models 3982 A,b,c&d Stag Array Res Leads	Medtronic, Inc.	GZB	Class II	1992-02-07
K913958	Flexiflo Quantum Enteral Nutrition Pump	Abbott Medical	LZH	Class II	1992-02-07
K913888	Med-Safe(tm) Latex Examination Gloves	Promed Corp.	LYY	Class I	1992-02-07
K913852	Laser Flare Meter	Kowa Pharmaceuticals America, Inc.	HJO	Class II	1992-02-07
K913736	Dobbhoff Anorect Biofeed Syst Five Div Fecal Const	Biosearch Medical Products, Inc.	FAP	Class II	1992-02-07
K913726	Duralife(tm)	Dhd Diemolding Healthcare Div.	BZA	Class I	1992-02-07
K913448	Disposable Turp Fluid Containment Drape - Sterile	Graham Medical Products	KKX	Class II	1992-02-07
K913447	Disposable Cystoscopy Splash Drape-Sterile #599	Graham Medical Products	KKX	Class II	1992-02-07
K912892	Auto-Vac Biopsy Needle	Angiomed GmbH & Co. Medizintechnik KG	KNW	Class II	1992-02-07
K912772	Superlogger	Diversatek Healthcare Inc	FFT	Class I	1992-02-07
K911066	Comfortron Pt (TENS)	M. D. Supply, Inc.	GZI	Class II	1992-02-07
K920131	Clarithromycin 15Mcg Sensi Disc	BD Becton Dickinson Vacutainer Systems Preanalytic	JTN	Class II	1992-02-06
K915792	Document Ck Isoenzymes Control	Casco Standards	CDP	Class II	1992-02-06
K915068	Plastic Disposable Surgical Light Handle Cover	American Medical Mfg., Inc.	FTA	Class II	1992-02-06
K914890	N/t Protein Control Uy	Behring Diagnostics, Inc.	JJY	Class I	1992-02-06
K914467	Milenia Total T3	Siemens Healthcare Diagnostics Inc.	CDP	Class II	1992-02-06
K913192	Simultest(tm) Imk-Lymphocyte	BD Becton Dickinson Vacutainer Systems Preanalytic	GKZ	Class II	1992-02-06
K915597	Bur,dental (76Ejl)	Calcitek, Inc.	DZE	Class II	1992-02-05
K915246	Conveen(r) Urisheath and Uriliner(male Exter Cath)	MEDLINE INDUSTRIES, LP - Northfield	EXI	Class I	1992-02-05
K915139	Model 2250-000 Zimmer Style Sagittal Saw Module	Micro Surgical Instruments Corp.	HSZ	Class I	1992-02-05
K915074	Irrigator/aspirator Probe	Biomedical Dynamics, Inc.	HMX	Class I	1992-02-05
K914483	Wetting Solution for Hard Contact Lenses	Optopics Laboratories Corp.	LPN	Class II	1992-02-05
K914457	Disposable Optical Valvulotome	Nobles-Lai Engineering, Inc.	MGZ	Class II	1992-02-05
K913487	Riwolith 2280	Richard Wolf Medical Instruments Corp.	FFK	Class II	1992-02-05
K913486	Qualtex Surgical Drape, Modification	DeRoyal Industries, Inc.	KKX	Class II	1992-02-05
K912783	Disposable Monopolar Needle Electrode	Class A Ent.	GXZ	Class II	1992-02-05
K915748	Aviva Mammographic X-Ray System	Elscint, Inc.	IZH	Class II	1992-02-04
K915414	Terumo Angiogtaphic Catheter	Terumo Medical Corp.	DQO	Class II	1992-02-04
K915405	P1310 Automatic Brightness Stabilizer (ABS)	Precise Optics Photo Medic Equipment, Inc.	JAA	Class II	1992-02-04
K914376	Dxs Digital X-Ray Subtraction	Philips North America LLC	IZI	Class II	1992-02-04
K913994	Monarch(tm) Inflation Syringe	Merit Medical Systems, Inc.	MAV	Class II	1992-02-04
K912944	CT 8000 Digital Injection System	Mallinckrodt Group, Inc.	DXT	Class II	1992-02-04
K912906	Medgraphics Pf/dx	Medical Graphics Corp.	BZL	Class II	1992-02-04
K912867	Oscor Medical Corp Permanent Pacing Lead	Oscor Medical Corp.	DTB	Class III	1992-02-04
K920100	Gsu Handpiece Adapter	Beacon Laboratories, Inc.	HAM	Class II	1992-02-03
K920086	Shock-Patch Adult Defibrillation Pads	Cardiotronics, Inc.	LDD	Class II	1992-02-03
K915799	Bivona Sleep Apnea Tube	Bivona Medical Technologies	BTR	Class II	1992-02-03
K915572	Becton Dickinson Modified Menghini Needle	BD Becton Dickinson Vacutainer Systems Preanalytic	GDM	Class I	1992-02-03
K915467	Cimpat S Dental Cement	Specialites Septodont	EMA	Class II	1992-02-03
K915466	Septopack Temporary Filling	Specialites Septodont	EBG	Class II	1992-02-03
K915445	Maaleable Facial Implant	Biomet Ussc Orthopedics	KKY	Class II	1992-02-03
K915350	Hydroxyapatite Infinity Trochanteric Module	Dow Corning Wright	MEH	Class II	1992-02-03
K915336	Twinlook	Kulzer GmbH	EBF	Class II	1992-02-03
K915276	Denture Plastic Teeth,76 Elm	Nobelpharma USA, Inc.	ELM	Class II	1992-02-03
K915196	Incare Hot/ice System 3	Hollister, Inc.	ILO	Class II	1992-02-03
K915089	Mitek Quickanchor(tm), Modification	Mitek Surgical Products, Inc.	GAS	Class II	1992-02-03