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 1990 of 3531

510(k) clearances, page 1990 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K960946	Echonet	Lockheed Martin Communications Systems	LLZ	Class II	1996-05-07
K960872	Cystoscope 0/15/30/70 Degrees	Pollux Endoscopy, Inc.	FAJ	Class II	1996-05-07
K960741	Comfortone Phs	Comfortone America'S Value Hearing Aid Line	ESD	Class I	1996-05-07
K960711	Acumed Bone Graft System	Acu Med, Inc.	KIJ	Class I	1996-05-07
K960665	Echo-Com for Ms-Windows Version 2.0	Cone Instruments, Inc.	LLZ	Class II	1996-05-07
K960575	Advantx Lcv+	GE Healthcare	IZI	Class II	1996-05-07
K960357	Dsl Active I-Hcg Irma	Diagnostic Systems Laboratories, Inc.	JHI	Class II	1996-05-07
K955635	Video Colposcope/vertical Rolling Base/swing Arm Stand	Welch Allyn Inc	HEX	Class II	1996-05-07
K954957	Codemaster Xl + Xl W/shock Advisory Option	Hewlett-Packard Co.	MKJ	Class III	1996-05-07
K953165	Ultra Compact Video Imager	International Imaging Electronics	LMC	Class II	1996-05-07
K952966	Cp-90 Continuous Positive Airway Pressure System	Nidek Medical Products Inc	BZD	Class II	1996-05-07
K952675	Orthofab Wheelchair	Orthofab, Inc.	ITI	Class II	1996-05-07
K950330	Digital Image Acquisition System	International Imaging Electronics	IYO	Class II	1996-05-07
K944599	Graham-Field Conductive ECG Spray	Chester Labs, Inc.	GYB	Class II	1996-05-07
K944598	Graham-Field Electrode Conductivity Gel	Chester Labs, Inc.	GYB	Class II	1996-05-07
K961474	Polyfin Infusion Set Mmt-106/Mmt-107/Mmt-133	Medtronic, Inc.	FPA	Class II	1996-05-06
K961043	Scantibodies Calcitonin Immunoradiometric Assay (Coated Bead Technology)	Scantibodies Laboratory Inc.	JKR	Class II	1996-05-06
K961005	Sargon Immediate Load Implant	Graham & James	DZE	Class II	1996-05-06
K960963	Cord Wrap with Needle Resheather	Osborn Medical Corporation	FMI	Class II	1996-05-06
K960697	Ultracid and Ultracid F Disinfecting Solution	Ultradent Products Inc.	KLE	Class II	1996-05-06
K960664	Barbiturate Serum Tox Eia Assay	Diagnostic Reagents, Inc.	DIS	Class II	1996-05-06
K960624	Certi Cool Instant Cold Compress	Certified Safety Mfg Inc	IMD	Class I	1996-05-06
K960616	Vitaflow Suction/aspiration Tubing Set	Vital Concepts, Inc.	BYY	Class II	1996-05-06
K960178	Comfit Brown, Beaded Surgeon's Gloves (Powdered, Hypoallergenic)	Wembley Rubber Products (M) Sdn Bhd	KGO	Class I	1996-05-06
K955410	Snapdose Device	Abbott Medical	FPA	Class II	1996-05-06
K955332	Opti-Max Externally Threaded Cylindrical Internal Bore Dental Implant, with Healing Screw	Opti-Max	DZE	Class II	1996-05-06
K955282	Thermogenesis Drop Applicator, Kits, Spray Kits and Tips	ThermoGenesis Corp.	FMF	Class II	1996-05-06
K935833	Lcx Neisseria Gonorrhoeae Assay	Abbott Medical	LSL	Class II	1996-05-06
K961098	Bio-Dressing, Sterile Island Dressing	K. W. Griffen Co.	MGP	Unclassified	1996-05-03
K961022	Tangent VI Table	Fischer Imaging Corp.	IXR	Class II	1996-05-03
K960678	Burch/schneider Reinforcement Cage	Intermedics Orthopedics	JDI	Class II	1996-05-03
K960655	Aesop System and Accessories	Computer Motion, Inc.	GCJ	Class II	1996-05-03
K960651	Cerclage Wire Crimp Block	Acu Med, Inc.	JDQ	Class II	1996-05-03
K960490	As/3 Compact Airway Module M-Caiov	Datex Medical Instrumentation, Inc.	CBS	Class II	1996-05-03
K960107	Dds Spinal System	Encore Orthopedics, Inc.	MNH	Class II	1996-05-03
K955573	Optiblast Intraoral Sandblaster	Buffalo Dental Mfg Co Inc	KOJ	Class II	1996-05-03
K954267	Burdick 200 Pulse Oximeter	Burdick Corp.	DQA	Class II	1996-05-03
K954221	Polymer Coated Chlorinated Powder-Free Latex Examination Gloves	Hartalega Sdn Bhd	LYY	Class I	1996-05-03
K953683	Mmuno Dot Borrelia Dot Blot M Test	Genbio	LSR	Class II	1996-05-03
K953682	Immuno Dot Borrelia Dot Blot G Test	Genbio	LSR	Class II	1996-05-03
K950484	Tbird Vs Ventilator and Tbird Avs Ventilator	Bird Products Corp.	CBK	Class II	1996-05-03
K961293	Quikcheck Unassayed Chemistry Control Levels 1 & 2	Consolidated Technologies, Inc.	JJY	Class I	1996-05-02
K960806	Turbo Tracker	Target Therapeutics	DQO	Class II	1996-05-02
K960429	Per-Fit Percutaneous Tracheostomy Kit W/portex Tracheostmy Tube & Disp. Inner Cannula	Smiths Industries Medical Systems, Inc.	JOH	Class II	1996-05-02
K960427	Abbott Cell-Dyn 3500R System	Sequoia Turner Corp.	GKZ	Class II	1996-05-02
K960377	Ena-C-T Total Cholesterol Test	Actimed Laboratories, Inc.	CHH	Class I	1996-05-02
K960180	22 Mm Cocr Head & Polyethlene Liner	Globus Medical, Inc.	LPH	Class II	1996-05-02
K955707	Onestep Urine/serum Hcg Module Pregnancy Test Kit	Excel Scientific, Inc.	DHA	Class II	1996-05-02
K955684	Rns Sterile, Disposable Angiographic Tray	Contour Fabricators of Florida, Inc.	DXT	Class II	1996-05-02
K954828	ISO-Gard Hepa Filter-Hme, ISO-Ard Hepa Filter-Hme W/port	Gibeck, Inc.	CAH	Class II	1996-05-02