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 1476 of 3531

510(k) clearances, page 1476 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K024145	Aigis-Xo	Sb Lucius, Inc.	EJT	Class II	2003-03-07
K024144	Aigis-Pt	Sb Lucius, Inc.	EJT	Class II	2003-03-07
K024139	Aigis-Inlay	Sb Lucius, Inc.	EJT	Class II	2003-03-07
K024122	Nautica Micro Catheter, Model 105-5094-153	Medtronic, Inc.	KRA	Class II	2003-03-07
K024074	Reprocessed Compression Sleeves	Alliance Medical Corp.	JOW	Class II	2003-03-07
K024061	Peregrine Straight Laser Probe, Model Pd6000.00	Peregrine Surgical, LLC.	GEX	Class II	2003-03-07
K024054	Xylos Xcell Antimicrobial Dressing	Xylos Corporation	MGQ	Unclassified	2003-03-07
K023097	Truezone Peak Flow Meter	Monaghan Medical Corp.	BZH	Class II	2003-03-07
K022167	Pall Doner Pre-Evacuated Post-Operative Autologous Blood Reinfusion System	Pall Corp.	CAC	Class II	2003-03-07
K012706	Im2001 Pulse Oximeter	Imagyn Medical Technologies, Inc.	DQA	Class II	2003-03-07
K030520	Intera Family	Philips North America LLC	LNH	Class II	2003-03-06
K030484	Syntheticare Powdered Vinyl Examination Gloves	Emerald Medical, Inc.	LYZ	Class I	2003-03-06
K030483	Syntheticare Powder-Free Vinyl Examination Gloves	Emerald Medical, Inc.	LYZ	Class I	2003-03-06
K030462	Cobe Revolution Centrifugal Blood Pump with Pc, Model 050300700	LivaNova USA, Inc.	KFM	Class II	2003-03-06
K030446	Repicci Locked Keel Tibial Bearing	Zimmer GmbH	HRY	Class II	2003-03-06
K030377	Modification to Synthes Cervifix System	Synthes (USA) Products LLC	MNI	Class II	2003-03-06
K030373	Alloclassic Zweymueller Sl/sll Femoral Stem	Centerpulse Orthopedics, Inc.	LZO	Class II	2003-03-06
K030372	Modification to Ebi Dynafix Diaphyseal Correction System	Ebi, LLC	KTT	Class II	2003-03-06
K030336	Kmedic External Fixation Devices	Teleflex Medical Group	JDW	Class II	2003-03-06
K024353	Sensititre 18-24 Hours Susceptibility Plates	Trek Diagnostic Systems, Ltd.	LTT	Class II	2003-03-06
K024141	Neo 76	Sb Lucius, Inc.	EJT	Class II	2003-03-06
K024140	Aigis-a	Sb Lucius, Inc.	EJT	Class II	2003-03-06
K023297	Urs-1B (Blood Test)	Teco Diagnostics	JIO	Class II	2003-03-06
K022855	Slendertone Flex Bottom & Thigh Toning System, Type 511	Bio-Medical Research, Ltd.	NGX	Class II	2003-03-06
K022609	Surgical Patient Warmer, Model Pw820 Jhu	Fisher & Paykel Healthcare, Inc.	ILY	Class II	2003-03-06
K030495	3.0T Torso Phased Array Coil	GE Healthcare	MOS	Class II	2003-03-05
K030449	Modification to Capiox Sx10 Hardshell Reservoir	Terumo Corp.	DTN	Class II	2003-03-05
K030075	Nitrile Powder-Free Medical Examination Glove (Blue) (Textured and Non-Textured)	Best Manufacturing Company-Distribution Center	LZA	Class I	2003-03-05
K024198	Smearclear	Sybron Dental Specialties, Inc.	KJJ	Unclassified	2003-03-05
K024113	IVD Crypto/giardia Dfa	IVD Research, LLC.	MHI	Class II	2003-03-05
K024065	Soft Venous Reservoir (Svrxx) with Gbs Coating	Gish Biomedical, Inc.	DTN	Class II	2003-03-05
K023888	Cimofluor	Global Dental Products, Inc.	EMA	Class II	2003-03-05
K022412	Fresenius Capd Stay.safe Disposable Administration Sets with Stay.safe Connector	Fresenius Medical Care Renal Therapies Group, LLC	KDJ	Class II	2003-03-05
K021546	Dermassist Fluid Resistant Surgical Mask with Wraparound Visor	Creative Contract (M) Sdn Bhd	FXX	Class II	2003-03-05
K021539	Dermassist Fluid Resistant Surgical Mask (Orange) and Procedure Mask with Tie-on and with Earloops	Creative Contract (M) Sdn Bhd	FXX	Class II	2003-03-05
K021533	Dermassist Procedure Mask/surgical Masks (Green, Blue, Yellow, Pink, White)	Creative Contract (M) Sdn Bhd	FXX	Class II	2003-03-05
K030509	Skintact ECG Tab Electrode	Leonhard Lang GmbH	DRX	Class II	2003-03-04
K030408	Cyto-Stat Tetrachrome Cd45-Fit/cd4-Pe/cd3-Pc5 Monoclonal Antibody Reagent, Cyto-Stat Tetrachrom Cd45-Fitc/cd56-Pe/cd19-a	Siemens Healthcare Diagnostics Inc.	GKZ	Class II	2003-03-04
K030344	Modular Neer 3 Humeral Stems and Modular Neer 3 Humeral Heads	Smith & Nephew, Inc.	KWS	Class II	2003-03-04
K030265	Cpt 12/14 Hip Prostheses, Model 00-8114-040/050-00	Zimmer GmbH	JDI	Class II	2003-03-04
K030250	Iglide Manual Assist Wheelchair	Independence Technology, LLC	ITI	Class II	2003-03-04
K030105	Anesthesia Monitor; Bedside Monitor, Series Bsm-5130A	Nihon Kohden America Inc	MHX	Class II	2003-03-04
K024346	The Multilift	Services Industriels Savaria, Inc.	ING	Class II	2003-03-04
K024336	Miig II Bone Graft Substitute	Wrightmedicaltechnologyinc	MQV	Class II	2003-03-04
K024171	Vidar Bone Track System Software	Vidar Systems Corp.	JAK	Class II	2003-03-04
K024015	Reprocessed Endoscopic Trocars and Cannulas	Alliance Medical Corp.	NLM	Class II	2003-03-04
K023852	Stairfriend Curved Stairway Chairlift	Services Industriels Savaria, Inc.	ILK	Class II	2003-03-04
K023377	Oria Cervical Plates	Ortho Tec, LLC	KWQ	Class II	2003-03-04
K023319	Nuvasive Mash	NuVasive Inc	MQP	Class II	2003-03-04
K023025	Self Seal Sterilization Pouch	Granton Medical, Ltd.	FRG	Class II	2003-03-04