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 980 of 3531

510(k) clearances, page 980 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K103403	Multiconstituent Calibrator	Abbott Medical	JIX	Class II	2011-02-04
K102753	Turbo Temp 3	Danville Materials, Inc.	EBG	Class II	2011-02-04
K101969	Mh1 Microholter Recorder	Exelys, LLC	MWJ	Class II	2011-02-04
K101842	Acies	Konica Minolta Medical & Graphic, Inc.	LLZ	Class II	2011-02-04
K101743	5Mm Flared Cannula Model 420262, 8Mm Flared Cannula Model 420319	Intuitive Surgical, Inc.	NAY	Class II	2011-02-04
K101673	Uritek Tc-101 Urine Analyzer, Urine Reagent Strips 10, Models Tc-101, Urs-10	Teco Diagnostics	JIL	Class II	2011-02-04
K101398	Stereos Workstation	Biospace Med	LLZ	Class II	2011-02-04
K101392	Neopac Software, 3007 Digital Photometer/fluorometer Model Na, 307 and 350D	Astoria-Pacific, Inc.	KQP	Class II	2011-02-04
K101353	Golden Gate Anterior Plate System	Ulrich GmbH & Co. KG	KWQ	Class II	2011-02-04
K101312	Nuvue Colormark9tm) Needle	Nuvue Therapeutics, Inc.	IYN	Class II	2011-02-04
K101077	Da Vinci Fluorescence Imaging Vision System, Model Ff 100	Intuitive Surgical, Inc.	GCJ	Class II	2011-02-04
K100371	Spy Intra-Operative Imaging System	Novadaq Technologies ULC	IZI	Class II	2011-02-04
K093835	Bam Standard Surgical Gown, Bam Reinforced Surgical Gown, Bam Ultra Reinforced Surgical Gown	Bam Corp., Ltd.	FYA	Class II	2011-02-04
K110045	Interfuse Da Invertebral Body Fusion Device	Vertebral Technologies, Inc.	MAX	Class II	2011-02-03
K103561	Menicon Z (Tisilfocon a) Rigid Gas Permeable Contact Lens	Menicon Co. Ltd.	HQD	Class II	2011-02-03
K103309	Osteoraptor Curved 2.3 Suture Anchors	Smith & Nephew Endoscopy, Inc.	MAI	Class II	2011-02-03
K103233	Modular Dual Mobility Liner, X3 Acetabular Insert	Howmedica Osteonics Corp	LZO	Class II	2011-02-03
K103020	Atlantis Abutment for Keystone Implant, Atlantis Gemini Abutment	Atlantis Components, Inc.	NHA	Class II	2011-02-03
K102892	Asi Deionizer & Carbon Exchange Service for Hemodialysis	Aqua Sciences, Inc.	FIP	Class II	2011-02-03
K102838	Patient Examination Gloves	Thai Hua Holding Co., Ltd.	LYY	Class I	2011-02-03
K102652	Non Reinforced Surgical Gowns, Film Reinforced Surgical Gowns, Fabric Reinforced Surgical Gowns	Gri Medical & Electronic Technology Co., Ltd.	FYA	Class II	2011-02-03
K102592	Sutrazorb	Visionary Medical Supplies, Inc.	GAM	Class II	2011-02-03
K102053	Butler Calci-Flor Prophylaxis Paste	Sunstar Americas, Inc.	EJR	Class I	2011-02-03
K101890	Ball Abutment System	Megagen Co., Ltd.	NHA	Class II	2011-02-03
K101801	Monica An24	Monica Healthcare	OSP	Class II	2011-02-03
K070049	Fresenius 2008K @Home with Wireless Wetness Detector	Fresenius Medical Care Renal Therapies Group, LLC	ONW	Class II	2011-02-03
K110009	Roadrunner Uniglide Hydrophilic Wire Guide	Cook Inc.	DQX	Class II	2011-02-02
K103629	Pet-512Mc Transesophageal Transducer	Toshiba America Medical Systems, In.C	ITX	Class II	2011-02-02
K103506	1.5T Head Coil (Hc150), 3T Head Coil (Hc300)	Imris, Inc.	MOS	Class II	2011-02-02
K103393	Polaris Spinal System	Highridge Medical, LLC	KWQ	Class II	2011-02-02
K103387	Mission Liquid Urine Control, Mission Liquid Diptube Urine Control, Mission Dry Strip Urine Control	Acon Laboratories, Inc.	JJW	Class I	2011-02-02
K103385	Securview Dx Diagnostic Workstation	Hologic, Inc.	LLZ	Class II	2011-02-02
K103347	Cardioroot Woven Collagen Coated Vascular Prostheses	Intervascular SAS	DSY	Class II	2011-02-02
K103213	Finess Endoscope Sterilization Tray	Entellus Medical, Inc.	KCT	Class II	2011-02-02
K103190	Profil Composites (Profil, Profil Flow)	Silmet Ltd.	EBF	Class II	2011-02-02
K103143	Arstasis One Latchwire Access System	Arstasis, Inc.	DYB	Class II	2011-02-02
K103113	Vasculaire Compression System	Venous Health Systems, Inc.	JOW	Class II	2011-02-02
K103011	Ulticare Safety Insulin Syringe	Ulti-Med Intl., Inc.	MEG	Class II	2011-02-02
K102995	Talon Spinal System	Spine360	MNI	Class II	2011-02-02
K102945	Pediacyn Atopic Dermatitis Hydrogel	Sonoma Pharmaceuticals, Inc.	FRO	Unclassified	2011-02-02
K102795	Signature Planner; Signature Guides	Materialise N.V.	JWH	Class II	2011-02-02
K102742	Nasal Cease	Catalina, Inc.	QSY	Unclassified	2011-02-02
K100948	Hypo Clenz Wound Wash Model 100 Ppm	Nevoa Life Sciences, LLC	FRO	Unclassified	2011-02-02
K100927	Surgiaid	Maxigen Biotech, Inc.	KGN	Unclassified	2011-02-02
K103056	Visulas Trion Laser System with the Vite Option	Carl Zeiss Meditec Inc	HQF	Class II	2011-02-01
K102238	Arrow(r) Nextstep Tm Antegrade Chronic Hemodialysis Catheter	Teleflexmedical, Inc.	MSD	Class II	2011-02-01
K110071	Cor Analyzer	Rcadia Medical Imaging, Ltd.	LLZ	Class II	2011-01-31
K103677	M7/m7t Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYN	Class II	2011-01-31
K103465	Synapse 3D Cardiac Tools	FUJIFILM Healthcare Americas Corporation	LLZ	Class II	2011-01-31
K103288	Deka Synchro Ft	El.en. Electronic Engineering SpA	GEX	Class II	2011-01-31