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 1312 of 3531

510(k) clearances, page 1312 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K050798	Eclipse Neurological Workstation	Axon Systems, Inc.	GWF	Class II	2005-08-15
K050575	Futumeds No Patient Contact Safety Lancet with Pals System	Futumeds Sdn Bhd	MDM	Class I	2005-08-15
K050320	Freescan Latex-Free Ultrasound Transducer Cover Kit	Ascendia Medtech AB	ITX	Class II	2005-08-15
K050262	U2 Acetabular Component	United Orthopedic Corp.	LWJ	Class II	2005-08-15
K043259	Bioblanket Surgical Mesh	DSM Biomedical, Inc.	FTM	Class II	2005-08-15
K043015	3L Surgical Drapes	3l Medical Products Co., Ltd.	KKX	Class II	2005-08-15
K052097	Ceram X Universal Mano-Ceramic Restorative	Dentsply International, Inc.	EBF	Class II	2005-08-12
K051932	Elekta Synergy; Elekta Synergy S and Xvir3.5	Elekta Limited	IYE	Class II	2005-08-12
K051900	Acuvue (Etafilcon a) Contact Lens, Clear and with Visibility Tint with UV Blocker, for Daily Wear	Johnson & Johnson Vision Care, Inc.	MVN	Class II	2005-08-12
K051897	Trio Monitor	Datascope Corp.	MWI	Class II	2005-08-12
K051827	Joimax Endoscope/multiscope, Thessys Foraminoscope/multiscope, Thessys Laminoscope/multiscope	Joimax GmbH	HRX	Class II	2005-08-12
K051777	Nitrile Powder Free Examination Gloves (Blue)	Hartalega Sdn Bhd	LZA	Class I	2005-08-12
K051748	Hemoglide Series and Hemoglide Star Series Xk Long-Term Hemodialysis Catheters	C.R. Bard Inc	MSD	Class II	2005-08-12
K051703	Clever Td-3018A Blood Pressure Monitor	Taidoc Technology Corporation	DXN	Class II	2005-08-12
K051606	Gish Atr2900 and Cap35 Series Reservoirs with Gbs Coating	Gish Biomedical, Inc.	DTN	Class II	2005-08-12
K051370	Sterile Saline for Device Care, Sterile Water for Device Care, Models 2F7121, 2F8014	Baxter Healthcare Corporation	JOL	Class II	2005-08-12
K051129	Discon (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear	Innova Vision Inc.	LPL	Class II	2005-08-12
K051038	506 Patient Monitor	Ciriticare Systems, Inc.	DRT	Class II	2005-08-12
K050899	Biogel Latex Sterile Powder-Free Glove	Regent Medical Americas, LLC	KGO	Class I	2005-08-12
K043260	Orthocon Llc Orthostat Hemostatic Bone Putty	Orthocon, Inc.	MTJ	Unclassified	2005-08-12
K052109	Sonosite Hand-Carried Ultrasound System (C1 Series)	FUJIFILM SonoSite,Inc.	IYN	Class II	2005-08-11
K052100	Modification to Motifmesh Soft Tissue Patch	Proxy Biomedical Ltd.	FTL	Class II	2005-08-11
K052039	Ge Oec Altitude	GE Healthcare	IZI	Class II	2005-08-11
K052001	Model Sr-115 Portable X-Ray System	Source-Ray, Inc.	IZL	Class II	2005-08-11
K051902	Nio 2Mp-21	Barco N.V.	LLZ	Class II	2005-08-11
K051848	Salute II Disposable Fixation Device, Models 0113070, 0113072, 0113073, 0113077, 0113079	Davol Inc., Sub. C.R. Bard, Inc.	GDW	Class II	2005-08-11
K051766	Orthomend	Integra LifeSciences Braintree Inc.	FTL	Class II	2005-08-11
K051644	Valleylab Forcetriad Electrosurgical Generator	Medtronic, Inc.	GEI	Class II	2005-08-11
K051533	I-Stop	CL MEDICAL Inc.	OTN	Class II	2005-08-11
K051505	Scb/steris or-Light Interface Box	Karl Storz Endoscopy-America, Inc.	FTA	Class II	2005-08-11
K051352	Oximax Npb-40 Handheld Pulse Oximeter	Medtronic, Inc.	DQA	Class II	2005-08-11
K051169	Biramed Biotech Borrelia B31 Igm Virablot	Viramed Biotech AG	LSR	Class II	2005-08-11
K051135	Axiom Nvp8500	Axiom Worldwide, Inc.	IPF	Class II	2005-08-11
K051071	Viramed Biotech Borrelia B31 Igg Virablot	Viramed Biotech AG	LSR	Class II	2005-08-11
K050984	Bioplant	Kerr Dental Materials Center	LYC	Class II	2005-08-11
K050869	Modification to Abl800 Flex	Radiometer Medical ApS	CIG	Class II	2005-08-11
K052011	Pilonplate with Angular Stability	I.T.S. Implantat-Technologie-Systeme GmbH	HRS	Class II	2005-08-10
K051955	Quickclot Acs - Accelerated Clotting Sponge	Z-Medica, LLC	QSY	Unclassified	2005-08-10
K051908	Charlotte Compression Plate	Wrightmedicaltechnologyinc	HRS	Class II	2005-08-10
K051605	Sbi K-Wires	Small Bone Innovations, Inc.	HTY	Class II	2005-08-10
K051479	Rs (Reduced Size) Oss (Orthopedic Salvage System) Additional Components	Biomet Manufacturing Corp	KRO	Class II	2005-08-10
K050824	100W Ceralas D 980 Laser System, Model D100	Biolitec, Inc.	GEX	Class II	2005-08-10
K050250	Aquify Multipurpose Solution	Alcon Laboratories	LPN	Class II	2005-08-10
K052113	Dp-6600 Ultrasonic Diagnostic Imaging System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYO	Class II	2005-08-09
K052053	Liquichek Qualitative Urine Toxicology Control, Negative, Positive, Minipak	Bio-Rad	DIF	Class I	2005-08-09
K052042	Sonoscape Ssi-1000/Ssi-5000 Ultrasound Transducers	Sonoscape Company Limited	IYN	Class II	2005-08-09
K052029	Syngo Circulation	Siemens AG Medical Solutions	JAK	Class II	2005-08-09
K051967	Revolution Xr/d Digital Radiographic Imaging System with Tomosynthesis	GE Healthcare	KPR	Class II	2005-08-09
K051941	Cybernife Stereotactic Radiosurgery System	Accuray Incorporated	MUJ	Class II	2005-08-09
K051802	Freestyle Connect Blood Glucose Monitoring System	Abbott Medical	NBW	Class II	2005-08-09