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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 806 of 3530

510(k) clearances, page 806 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K130199	Clarity Lpc Laser System	Lutronic Corporation	GEX	Class II	2013-11-22
K123090	Glb Benecheck Premium Glu Monitoring System	General Life Biotechnology Co., Ltd.	NBW	Class II	2013-11-22
K121587	Breath Shake	Cheen Houng Ent. Co. Ltd.	BYI	Class II	2013-11-22
K132306	Persyst 12 EEG Review and Analysis Software	Persyst Development LLC	OMB	Class II	2013-11-21
K132066	Inflamma Dry	Rapid Pathogen Screening, Inc.	PFQ	Class I	2013-11-21
K130831	Maldi Biotyper Ca (Mbt-Ca) System	Bruker Daltonics	PEX	Class II	2013-11-21
K130514	Audifon Arriva Cic, Is, Is+, M, S, S+, X Trt, Audifon Vico, Audifon Prado, Audifon Elia, Cic, Is, Is+, M, S Trt	Audifon-USA, Inc.	KLW	Class II	2013-11-21
K123977	Randox Liquid Ck-Mb, Randox Ck-Mb Calibrator	Randox Laboratories, Limited	CGS	Class II	2013-11-21
K133264	Nmi Picc III	Boston Scientific Corporation	LJS	Class II	2013-11-20
K133008	Bnx Delivery System Pre-Loaded with 19, 22 and 25 Gauge Needle, 19, 22 or 25 Gauge Needles (Individually Sterile-Packed,	Beacon Endoscopic	FCG	Class II	2013-11-20
K132971	Monaco	Elekta Limited	MUJ	Class II	2013-11-20
K132893	Edge Orthopaedics Bite Compression Screw	Icon Orthopaedic Concepts dba Edge Orthopaedics	HWC	Class II	2013-11-20
K132847	I2c	Ion Beam Applications S.A.	LHN	Class II	2013-11-20
K132821	Agamatrix Health Manager	Agamatrix	NBW	Class II	2013-11-20
K132808	Vital Signs Monitor, Connex Vital Signs Monitor	Welch Allyn Inc	MWI	Class II	2013-11-20
K132757	Everest Spinal System	K2M, Inc	MNI	Class II	2013-11-20
K132655	Retroarc Retropubic Sling System	American Medical Systems, Inc.	OTN	Class II	2013-11-20
K132603	Apex Spine System	Spinecraft LLC	NKB	Class II	2013-11-20
K132411	Affix II Spinous Process Plate System	Nu Vasive, Incorporated	PEK	Class II	2013-11-20
K132347	Multicam 3000 Eco	Inter Medical Medizintechnik GmbH	KPS	Class II	2013-11-20
K132168	Bronchoscopy Elbow	Respironics, Inc.	BZD	Class II	2013-11-20
K131689	MRI Marker	C4 Imaging LLC	KXK	Class II	2013-11-20
K131387	Wright Gradient 52 - Torso	Wright Therapy Products, Inc.	JOW	Class II	2013-11-20
K130707	Isirona Magellan	Isirona, LLC	MSX	Class II	2013-11-20
K130230	Sterile Piston Hypodermic Syringes (With/without Needle), Hypodermic Needles	Wuxi Yushou Medical Applicances Co., Ltd.	FMF	Class II	2013-11-20
K130212	Safety Hypodermic Needles With/without Syringe	Wuxi Yushou Medical Applicances Co., Ltd.	FMI	Class II	2013-11-20
K122438	Hamilton-Mr1	Hamilton Medical AG	CBK	Class II	2013-11-20
K133276	V.a.c. Granufoam Dressing, Granufoam Thin Dressing, Granufoam Round Dressing, Granufoam Silver Dressing, Whitefoam Dress	KCI USA, Inc.	OMP	Class II	2013-11-19
K132898	A.l.p.s. Calcaneal Plating System	Biomet Manufacturing Corp	HRS	Class II	2013-11-19
K132779	Dc-N2/dc-N2s Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYN	Class II	2013-11-19
K132750	Illumina Miseqdx Cystic Fibrosis Clinical Sequencing Assay	Illumina, Inc.	PFS	Class II	2013-11-19
K132712	Affinity Cp Centrifugal Blood Pump with or without Coating, Affinity Cp Adapter	Medtronic, Inc.	KFM	Class II	2013-11-19
K132258	Zimmer Dental Trabecular Metal Implant System	ZimVie US Corp LLC	DZE	Class II	2013-11-19
K131377	Hemicap Mtp Resurfacing Hemi-Arthroplasty Implant	Arthrosurface, Inc.	KWD	Class II	2013-11-19
K130426	Sumitomo Proton Therapy System	Sumitomo Heavy Industries, Ltd.	LHN	Class II	2013-11-19
K124006	Illumina Miseqdx Cystic Fibrosis 139-Variant Assay	Illumina, Inc.	PFR	Class II	2013-11-19
K123148	Parace Md Ekoscope Is100	Parace, LLC	DQD	Class II	2013-11-19
DEN130042	Miseqdx Universal Kit 1.0	Illumina, Inc.	PFT	Class I	2013-11-19
DEN130011	Illumina Miseqdx Platform	Illumina, Inc.	PFF	Class II	2013-11-19
K133102	Flower Ankle Plating Set	FLOWER ORTHOPEDICS Corporation dba Conventus Flower	HRS	Class II	2013-11-18
K132968	Univise Spinous Process Fixation Plate (35Mm, 40Mm)	Howmedica Osteonics Corp	PEK	Class II	2013-11-18
K132859	Integra Facet Fixation System	Seaspine, Inc.	MRW	Unclassified	2013-11-18
K132718	Integrity Spine Core System	Integrity Spine	ODP	Class II	2013-11-18
K132261	Discovery Xr656 with Volumerad (Digital Tomosynthesis)	GE Healthcare	IZF	Class II	2013-11-18
K131782	Loqteq High Tibia Osteotomy Plate 4.5	AAP Implantate AG	HRS	Class II	2013-11-18
K133142	Volcano Lomap,volcano Lomap Option Kit for Mobile System,volcano Lomap Option for Integrated System,volcano S5 Precision	Volcano Corporation	IYO	Class II	2013-11-15
K133140	Bd Veritor System for the Rapid Detection of Rsv	Becton Dickinson & Co	GQG	Class I	2013-11-15
K133031	Sharpsology 2	Industrial Water Solutions, Inc.	MMK	Class II	2013-11-15
K132951	Magnetom Aera	Siemens Medical Solutions USA, Inc.	LNH	Class II	2013-11-15
K132741	V.a.c. via Negative Pressure Wound Therapy System	KCI USA, Inc.	OMP	Class II	2013-11-15