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 1100 of 3531

510(k) clearances, page 1100 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K083046	Fora Telehealth System	Taidoc Technology Corporation	DRG	Class II	2009-01-16
K082887	Pm-1000F+patient Monitor	Advanced Instrumentations, Inc.	MWI	Class II	2009-01-16
K082728	Vertex Recontruction System, Vertex Select Reconstruction System	Medtronic Sofamor Danek USA Inc	KWP	Class II	2009-01-16
K082626	Pam 3000	Wireless 2000 RF & Uwb Technologies, Ltd.	DRT	Class II	2009-01-16
K082521	Easy2check Blood Glucose and Blood Pressure Monitoring System	Card Guard Scientific Survival, Ltd.	NBW	Class II	2009-01-16
K082518	Dual Needle Suture Passer System	Cayenne Medical Inc.	GAT	Class II	2009-01-16
K082511	Medigard Blood Collection Device	Medigard Limited	FMI	Class II	2009-01-16
K081908	Cliniqa Liquid Qc Urinalysis Controls, Levels 1 and 2	Cliniqa Corporation	JJW	Class I	2009-01-16
K081641	Coulter Lin-X Linearity Control	Siemens Healthcare Diagnostics Inc.	JPK	Class II	2009-01-16
K081499	Health Manager, Version 1.1	Biocomfort Diagnostics GmbH & Co. KG	DRG	Class II	2009-01-16
K081307	Omnilux Clear-U	Photo Therapeutics Limited	OLP	Class II	2009-01-16
K081193	Cobas Integra 400/800 Bilirubin Total	Roche Diagnostics GmbH	CIG	Class II	2009-01-16
K072102	Epivision Sl System	Gebauer Medizintechnik GmbH	HNO	Class I	2009-01-16
K090004	Levitronix, Thoratec Centrimag Back-Up Consoles	Levitronix, LLC	DWA	Class II	2009-01-15
K083872	Imns Medacta Navigation System	Medacta International SA	OLO	Class II	2009-01-15
K083839	Avaulta Solo Synthetic Support System, Avaulta Plus Biosynthetic Support System	C.R. Bard Inc	OTP	Class III	2009-01-15
K083537	Modification to Medwaves Microwave Coagulation/ablation System	Medwaves Incorporated	NEY	Class II	2009-01-15
K083495	Modification to: Metha Hip System	Aesculap Inc	LZO	Class II	2009-01-15
K083430	Real-Time PCR Internal Control 2B Set	Nanogen, Inc.	OLD	Class I	2009-01-15
K083150	G-Force Tenodesis Screw	Wrightmedicaltechnologyinc	MBI	Class II	2009-01-15
K082996	Biolox Delta Option Ceramic Heads	Zimmer GmbH	LZO	Class II	2009-01-15
K082955	Ethicon Endo-Surgery Articulating Hook Knife, Model In4505	Ethicon Endo-Surgery Inc	GEI	Class II	2009-01-15
K082716	A-Dec/w&h Alegra Air-Driven Highspeed Handpiece, Model Te-97, Te-98, a-Dec/w&h Alegra Handpiece Attachment, Model He-43	A-dec, Inc.	EFB	Class I	2009-01-15
K082617	Trauson General Spinal System (Gss)	Trauson (Jiangsu) Medical Instrument Co., Ltd.	MNI	Class II	2009-01-15
K082337	Minnie Support Catheter	Vascular Solutions LLC	DQY	Class II	2009-01-15
K082115	Phoglass Fill, Core, Cem, Seal, Prime and Phoglass Protect	S & C Polymer GmbH	EMA	Class II	2009-01-15
K081911	Non-Sterile, Powdered Nitrile Examination Glove, Blue	Siam Sempermed Corp., Ltd.	LZA	Class I	2009-01-15
K081377	Nuvasive Surgical Mesh System	NuVasive Inc	FTL	Class II	2009-01-15
K081054	Gish Arterial Filter with Ha Coating	Gish Biomedical, Inc.	DTM	Class II	2009-01-15
K081033	Miroxi	Mir Medical Intl. Research SRL	DQA	Class II	2009-01-15
K083916	Lcd3090wqxi or Md304mc 29.8 Inch Diagnostic Imaging Lcd Monitor, Model L307td	Nec Display Solutions, Ltd.	LLZ	Class II	2009-01-14
K083769	Modification to Uresta Pessary	Eastmed, Inc.	HHW	Class II	2009-01-14
K083149	Arterial Health Package (Ahp) Software	Siemens Medical Solutions USA, Inc.	LLZ	Class II	2009-01-14
K083025	Synthes 4.5 Mm Va-Lcp Curved Condylar System	Synthes (USA) Products LLC	HRS	Class II	2009-01-14
K082748	Atrium Prolite S Mesh	Atrium Medical Corporation	FTL	Class II	2009-01-14
K082406	Expandable Peek-Optima Implant	Ebi, LLC	MAX	Class II	2009-01-14
K081396	Swissplant Dental Implant System	Implant Direct, LLC	NHA	Class II	2009-01-14
K081378	Dri Methadone Metabolite (100/300) Assay, Calibrators and Controls	Thermo Fisher Scientific Oy	DJR	Class II	2009-01-14
K081101	Spectra-System Abutments 2008	Implant Direct, LLC	NHA	Class II	2009-01-14
K081064	Giardia Fecal Antigen Detection Lateral Flow Kit, Model Gl-Lf	IVD Research, LLC.	MHI	Class II	2009-01-14
K080964	Fresenius Model 2008T Hemodialysis Machine	Fresenius Medical Care Renal Therapies Group, LLC	KDI	Class II	2009-01-14
K083907	Md212mc 21.3 Diagnostic Imaging Lcd Monitor-L217tg	Nec Display Solutions, Ltd.	LLZ	Class II	2009-01-13
K083877	Flying Diagnostic Ultrasound System	Neusoft Medical Systems Co., Ltd.	ITX	Class II	2009-01-13
K083837	Jetstream G2 System, Models Pv20300 (Jetstream G2 Catheter and Control Pod); Pvcn100 (Pv Console)	Pathway Medical Technologies, Inc.	MCW	Class II	2009-01-13
K083814	Outback Ltd Re-Entry Catheter, Model: Otb42120	Cordis Corp., A Johnson & Johnson Co.	PDU	Class II	2009-01-13
K083743	Capsure Ps System	Spine Wave Inc	MNI	Class II	2009-01-13
K083417	Intratemp Solution Warmer	C Change Surgical LLC	LHC	Class I	2009-01-13
K083167	Phenix Cervical Interbody Device	Spinal Devices, LLC	ODP	Class II	2009-01-13
K083166	Specialty Coils for the Magnetom Essenza	Siemens Medical Solutions USA, Inc.	MOS	Class II	2009-01-13
K083155	Hd Camera Head Otv-S7proh-Hd-L08e	Olympus Medical Systems Corp.	FET	Class II	2009-01-13