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 2021 of 3531

510(k) clearances, page 2021 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K951038	Oxycheck Oxygen Monitor	Oxycheck, Inc.	CCL	Class II	1996-01-11
K940564	Ideia(tm) Chlamydia Blocking Reagents, Modification	Dako Diagnostics, Ltd.	LJC	Class I	1996-01-11
K955552	Expressaire Toruniquet System	Smith & Nephew Richards, Inc.	KCY	Class I	1996-01-05
K955140	2.0 X 6Mm Screw	Brasseler USA I, L.P.	DZL	Class II	1996-01-05
K954839	Aspartate Aminotransferase Procedure No.. 58-UV	Sigma Diagnostics, Inc.	CIT	Class II	1996-01-05
K954791	Seminal Fluid Collection Kit II	Apex Medical Technologies, Inc.	HIS	Class II	1996-01-05
K954705	Acrysteel Blocking Tray	Medtec LLC	IYE	Class II	1996-01-05
K954678	Pro Vision	Algotec Systems, Ltd.	LLZ	Class II	1996-01-05
K954589	Clark Tut Image Processing System	Clark Research and Development, Inc.	LLZ	Class II	1996-01-05
K954248	Siemens Virtural Wedge	Siemens Medical Solutions USA, Inc.	IXI	Class II	1996-01-05
K954031	Compu-Blend Epilator	R. A. Fischer Co. Corp.	KCW	Class I	1996-01-05
K953879	Surgeon's Cap	American Threshold Industries, Inc.	FYF	Class I	1996-01-05
K953878	Bouffant Cap	American Threshold Industries, Inc.	FYF	Class I	1996-01-05
K953258	Titanium Hemostatic Clip	Intramed Laboratories, Inc.	FZP	Class II	1996-01-05
K953077	Paragon Cze 2000 Clinical Capillary Electrophoresis System	Beckman Instruments, Inc.	CDF	Class I	1996-01-05
K952585	Gamp & Associates Disposable End Irrigating Endoilluminator	Gamp & Assoc.	MPA	Class II	1996-01-05
K952581	Gamp & Associates Disposable Fiberoptic Viscoinjector	Gamp & Assoc.	MPA	Class II	1996-01-05
K952569	Gamp & Associates Three Function Disposable Manipulator	Gamp & Assoc.	HQR	Class II	1996-01-05
K951999	Holopsy System	Neovision Corp.	IYO	Class II	1996-01-05
K955763	Optilux 400	Demetron Research Corp.	EBZ	Class II	1996-01-04
K955336	Snorefree	Scott Feldman Dds & Norman Shapiro Dds	LRK	Class II	1996-01-04
K955333	Spirit Mb	Ormco Corp.	DYW	Class II	1996-01-04
K955053	Nipro Scalp Vein Set (Disposabl Psv Set)	Nissho Corp.	FOZ	Class II	1996-01-04
K954991	Phase Change Dental Lubricant	Phase Change	EFB	Class I	1996-01-04
K954827	Sealite Fl	Sybron Dental Specialties, Inc.	EBC	Class II	1996-01-04
K954763	Bio-Interfaces, Inc,. Bii-Plast	Bio-Interfaces, Inc.	LYC	Class II	1996-01-04
K954720	Strato/infusaif Infuse-a-Cath Central Venous Catheters	Strato/Infusaid, Inc.	LJS	Class II	1996-01-04
K954609	Heartstart 911	Laerdal Medical a/S	MKJ	Class III	1996-01-04
K954603	Durasoft Freshlook UV Colors; Durasoft 3 Freshlook UV Lite Tint	Wesley Jessen Corp.	LPL	Class II	1996-01-04
K953707	Medtrol Dental Kit	Medtrol, Inc.	EKJ	Class I	1996-01-04
K953462	Patient Examination Gloves	P.T. Irama Dinamika Latex	LYY	Class I	1996-01-04
K953461	CPR Mask & Related Family Kits	Safetec of America, Inc.	CBP	Class II	1996-01-04
K951978	Hewlett-Packard Model M1791a Acute Cardiac Ischemia-Time Insensitive Predicitive Instrument (Aci-Tipt)	Hewlett-Packard Co.	LOS		1996-01-04
K950988	Holter 6000	Omega Medical Services, Inc.	DQK	Class II	1996-01-04
K942709	Mediastinal Silicone Drains	Sil-Med Corp.	GBW	Class I	1996-01-04
K933646	Cal-Form Dental Implants	Cal-Form, Inc.	DZE	Class II	1996-01-04
K955611	Kmanz II	Gatorz LLC	HQY	Class I	1996-01-03
K955539	Unisun	Steven Chen	HQY	Class I	1996-01-03
K955442	Kowa Sc-1200 Photo Slit Lamp System	Kowa Pharmaceuticals America, Inc.	HKI	Class II	1996-01-03
K955185	Ge Advantage Dicom Cr Reprocessing Station	GE Healthcare	LLZ	Class II	1996-01-03
K952260	Op-2 (Lotifocon B) & Op-6 (Lotifocon C)	Stellar Contact Lens, Inc.	HQD	Class II	1996-01-03
K951823	Cryo Check Low Fibrinogen Control	Precision Biologicals, Inc.	GGN	Class II	1996-01-03
K944314	Disposable Tm-E Cochgtrode - Blsc Part No. 101123	Bio-Logic Systems Corp.	GXY	Class II	1996-01-03
K955759	Litex 680	Dentamerica	EBZ	Class II	1996-01-02
K955331	Belleglashp	Sybron Dental Specialties, Inc.	EBG	Class II	1996-01-02
K954875	Aspect Acquisition Module (Aam)	Aspect Electronics, Inc.	LMA	Class II	1996-01-02
K954631	Osteograf/n-Blocck Hydroxylapatite	Ceramed Corp.	LYC	Class II	1996-01-02
K954020	Micro Therapeutics Sidehole Infusion Wire	Medtronic, Inc.	KRA	Class II	1996-01-02
K952541	Pacifier Thermometer	Regitar U.S.A., Inc.	FLL	Class II	1996-01-02
K952527	Balloon Uterine Stent	Cook Incorporated	KNA	Class II	1996-01-02