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 1032 of 3531

510(k) clearances, page 1032 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K093571	Zr Dental Block	Ams Co., Ltd.	EIH	Class II	2010-03-12
K093556	Vcare Dx	ConMed Corporation	LKF	Class II	2010-03-12
K093213	Guided Progression Analysis on the Humphrey Field Analyzer II and II -I Series	Carl Zeiss Meditec Inc	HPT	Class I	2010-03-12
K092950	Solaris Models Nt1 and Nt1a Handheld Pulse Oximeters with Sensor Accessories	Solaris Medical Technology, Inc.	DQA	Class II	2010-03-12
K092922	Ssi-8000/S8/s6 Digital Color Doppler Ultrasound System, 2P1 Phased Array Diagnostic Ultrasound Transducer	Sonoscape Company Limited	IYN	Class II	2010-03-12
K092784	C. Albicans/c. Glabrata Pna Fish	Advandx, Inc.	NZS	Class I	2010-03-12
K092322	Elecsys Rubella Igm Immunoassay	Roche Diagnostics GmbH	LFX	Class II	2010-03-12
K092265	Vesafitcup Double Mobility- Highcross Hxuhmwpe Liners	Medacta International SA	MEH	Class II	2010-03-12
K091722	Coaxial Applicator System	Zimmer GmbH	FMF	Class II	2010-03-12
K100352	Diagnosoft Harp Model 2.06	Diagnosoft, Inc.	LNH	Class II	2010-03-11
K100094	Carestream Image Suite	Carestream Heatlh, Inc.	LLZ	Class II	2010-03-11
K093936	Romeo Posterior Osteosynthesis System	Spineart SA	MNI	Class II	2010-03-11
K093864	Avs Align Peek Spacers Model 48328Xxx, 48326Xxx	Stryker Corp.	MAX	Class II	2010-03-11
K093787	Iguide Cappa	Cas Innovations GmbH & Co. KG	JAK	Class II	2010-03-11
K092980	Panpac Uterine Manipulator Injector, Model Umi 4.5	Panpac Medical Corporation	LKF	Class II	2010-03-11
K092886	Well Lead Endobronchial Tubes	Well Lead Instruments	CBI	Class II	2010-03-11
K092852	Saview 58 UV; Toric & Multifocal (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear	St. Shine Optical Co., Ltd.	LPL	Class II	2010-03-11
K092847	840 Ventilator System with Expanded Neomode Option	Covidien, Formerly Nellcor Puritan Bennett, Inc.	CBK	Class II	2010-03-11
K092474	Pyrenees Cervical Plate System, Semi-Constrained Screws	K2M, Inc	KWQ	Class II	2010-03-11
K092181	Hemosil Acustar Cardiolipin Igg, Igm and Igg and Igm Controls	Instrumentation Laboratory Co.	MID	Class II	2010-03-11
K091656	Sps-1Tm Static Preservation Solution, Models Sps-1-500 Ml, Sps 1-1L, Sps-1-2L	Organ Recovery Systems, Inc.	KDL	Class II	2010-03-11
K100506	Force Fiber Green Ultra High Molecular Weight Polyethylene Non Absorbable Sutures Model:x-5000Ffk, X-5001Ffk, X-5002Ffk	Teleflex Medical	GAT	Class II	2010-03-10
K100346	Endoclear System	Virtual Ports Ltd	GCJ	Class II	2010-03-10
K100115	Xvi R4.5	Elekta Limited	IYE	Class II	2010-03-10
K100053	Mattioli Pulse Two/three Plus Family	Mattioli Engineering Corp.	ONF	Class II	2010-03-10
K094037	Tc Plating System	Ortho-Pro, LLC	HRS	Class II	2010-03-10
K093773	Amsino i.v. Administration Set, Amsafe3 i.v Administration Set, Extension Sets	Amsino International, Inc.	FPA	Class II	2010-03-10
K093744	Excite F and Excite Dsc	Ivoclar Vivadent, Inc.	KLE	Class II	2010-03-10
K093708	Telio Cad	Ivoclar Vivadent, Inc.	EBG	Class II	2010-03-10
K093620	Pulpdent Fluoride Varnish	Pulpdent Corporation	LBH	Class II	2010-03-10
K093526	V.a.c. via Therapy System, V.a.c. via Negative Pressure Therapy Unit, V.a.c. via Dressing (Containing V.a.c. Granufoam D	Kci USA, Inc. (Kinetic Concepts, Inc.)	OMP	Class II	2010-03-10
K093507	Olympus Chf Type Y0003	Olympus Medical Systems Corp.	FBN	Class II	2010-03-10
K093384	Mission Trinity R (Level 1) (Level 2) (Level 3), (Level 1,2,3)	DIAMOND DIAGNOSTICS Inc	JJY	Class I	2010-03-10
K093124	Puresom Nasal Mask-Small, Puresom Nasal Mask-Medium, Puresom Nasal Mask-Large, Models 11924-01, 11924-02, 11924-03	Cardinal Health 207, Inc.	BZD	Class II	2010-03-10
K092930	Nexus Intravascular Tubing Sets-Pre-Pierced	Nexus Medical, LLC	FPA	Class II	2010-03-10
K092908	Neomed Sterile Syringe, Models Sd-S1eo, Sd-S3eo, Sd-S630, Sd-S12eo, Sd-S20eo, Sd-S35eo, Sd-S60eo	Halyard Health	FMF	Class II	2010-03-10
K092786	Inbody, Models: 270, R20, R20b	Biospace Inc.	MNW	Class II	2010-03-10
K092545	Inomax Ds (Delivery System), Model 10003	Mallinckrodt Manufacturing LLC	MRN	Class II	2010-03-10
K092414	Conmed Detachatip Instrument Tray, 33Cm and 43Cm	ConMed Corporation	KCT	Class II	2010-03-10
K092409	Hydro-Guard Mini Breathing Filter and Heat and Moisture Exchanger and Air-Guard Clear Breathing Filter	Intersurgical Ltd.	CAH	Class II	2010-03-10
K092383	Bovie Icon Vs General Purpose RF Generator, Model: Vs300	Apyx Medical Corporation	GEI	Class II	2010-03-10
K092141	Vanish Varnish, 5% Sodium Fluoride White Varnish	3M ESPE Dental Products	LBH	Class II	2010-03-10
K092089	Clarujust	Audigence, Inc.	EWO	Class II	2010-03-10
K091975	Integrated Laboratory Automation Solution	Integrated Laboratory Automation Solutions, Inc.	CGA	Class II	2010-03-10
K091520	Immulisa Celiac Ttg Iga and Igg Antibody Elisa	Immco Diagnostics, Inc.	MVM	Class II	2010-03-10
K083803	Fixit Headrest Clamp System	Medicon, E.G.	HBL	Class II	2010-03-10
K100500	Psl Classic Slit Lamp	Keeler Instruments, Inc.	HJO	Class II	2010-03-09
K100048	E1 Antioxidant Infused Technology	Biomet Manufacturing Corp	OIY	Class II	2010-03-09
K093779	Clearpath Ugi	Easyglide, Ltd.	FDS	Class II	2010-03-09
K093668	Synthes Matrix Mis Rods	Synthes (USA) Products LLC	NKB	Class II	2010-03-09