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 1010 of 3531

510(k) clearances, page 1010 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K101180	Gripper Micro Blunt Cannula, Non-Coring Safety Needle (Gripper Micro Needle) Model: 21-3253-24, 21-3258-24, 21-3262-24,	Abbott Medical	FPA	Class II	2010-08-03
K100966	Colonoscope/sigmoidoscope Sheathes	Sheathing Technologies Inc	FDF	Class II	2010-08-03
K100776	Synthes 2.4 Mm/2.7 Mm Variable Angle Lcp Forefoot/midfoot System	Synthes (USA) Products LLC	HRS	Class II	2010-08-03
K100288	Neomed Enteral Only Extension Set	Halyard Health	KNT	Class II	2010-08-03
K092892	1-M Graduated Compression Anti-Embolism Stocking, Model Ss-811, Ss-508, Ss-613	I-Ming Sanitary Materials Co., Ltd.	DWL	Class II	2010-08-03
K092721	Align Radial Head System	Skeletal Dynamics, Inc	KWI	Class II	2010-08-03
K101981	Optetrak Logic Combination Tibial Tray	Exactech, Inc.	JWH	Class II	2010-08-02
K101909	Exactech Equinoxe, Platform Fracture Stem	Exactech, Inc.	PHX	Class II	2010-08-02
K101653	Miltex Thompson Cassettes; Miltex Surgical Cassettes	Miltex, Inc.	KCT	Class II	2010-08-02
K101409	System Ie Liquid Chemical Cterilant Processing System	STERIS Corporation	MED	Class II	2010-08-02
K101207	Neodent Implant System	Jjgc Industria E Comercio de Materiais Dentarios S	DZE	Class II	2010-08-02
K100946	Intravscular Administration Set	Terumo Europe N.V.	FPA	Class II	2010-08-02
K100851	Range Spinal System	K2M, Inc	MNI	Class II	2010-08-02
K100819	The Solopath Balloon Expandable Transfemoral Introducer	Onset Medical Corporation	DYB	Class II	2010-08-02
K100741	Reverse Shoulder Prosthesis Monoblock Stem, Reverse Shoulder Prosthesis Humeral Inserts, Model 510-00-006/012	Encore Medical, LP	PHX	Class II	2010-08-02
K100556	Slendertone Flex Max, Model 517 US	Bio-Medical Research, Ltd.	NGX	Class II	2010-08-02
K100502	Ascension Total Plate System	Ascension Orthopedics, Inc.	HRS	Class II	2010-08-02
K100200	Advia Chemistry Acetaminophen Reagent, Model Ref 07989138	Siemens Healthcare Diagnostics Inc.	LDP	Class II	2010-08-02
K093079	Touchsoft Coagulator with Banana Fitting, Model 4581 and with Universal Fitting, Model 4581-U	Hobbs Medical, Inc.	KNS	Class II	2010-08-02
K092937	Sta-Hybrid Hep Calibrator	Diagnostica Stago, Inc.	JIT	Class II	2010-08-02
K091303	Liquichek Hematology-16 Control Lv, Model: 295Lv	Bio-Rad Laboratories Inc.	JPK	Class II	2010-08-02
K101507	Amigo Classic Fd	Amigo Mobility Intl., Inc.	INI	Class II	2010-07-30
K101423	Optibond Xtr	Sybron Dental Specialties, Inc.	KLE	Class II	2010-07-30
K101386	Vigilant EEG Monitor Model Vigilant 2.0	Infinite Biomedical Technologies, LLC	GWQ	Class II	2010-07-30
K101296	Zimmer Segmental System Proximal Femoral Component and Small Diameter Stem Extensions	Zimmer GmbH	LZO	Class II	2010-07-30
K101281	Vega Knee System	Aesculap Implant System, Inc.	JWH	Class II	2010-07-30
K101010	Fully Automatic Electronic Blood Pressure Monitor Model: Kd-5963Nu, Kd-5008	Andon Health Co., Ltd	DXN	Class II	2010-07-30
K093000	Ems Piezon Master 700	E.M.S. - Electro Medical Systems SA	ELC	Class II	2010-07-30
K091018	Arthrex Biowire	Arthrex GmbH	GAS	Class II	2010-07-30
K102050	Q-Switched Nd:yag Laser System, Model Globalcure-Sc6	Advanced Technology Laser Co., Ltd.	GEX	Class II	2010-07-29
K101521	St/ar St and Arrhythmia Software Model: Release K.o	Philips North America LLC	MHX	Class II	2010-07-29
K101261	Catheter Repair Kit with Replacement Connector, Model 5587000	C.R. Bard Inc	NFK	Class II	2010-07-29
K100889	Endoskeleton Tc	Titan Spine, LLC	ODP	Class II	2010-07-29
K100654	Zoll Propaq Md	ZOLL Medical Corporation	LDD	Class II	2010-07-29
K093724	Fora Control Solution, Taidoc Control Solution	Taidoc Technology Corporation	JJX	Class I	2010-07-29
K093608	Gambro Water Purification Unit, Models Wro 300 and Wro 300 H	Gambro Renal Products	FIP	Class II	2010-07-29
K093489	In Vision-Plus Nano with Neutral Advantage Technology	RyMed Technologies, LLC	FPA	Class II	2010-07-29
K093342	Biogennix Rpc	Biogennix, LLC	MQV	Class II	2010-07-29
K102002	Talymed	Marine Polymer Technologies, Inc.	FRO	Unclassified	2010-07-28
K101949	Pediatric Body-Cardiac Coil, Model: 5000012601	Shanghai Chenguang Medical Technologies Co, Ltd	MOS	Class II	2010-07-28
K101879	Xpert Mrsa/sa Bc (Blood Culture) Assay Model Gxmrsa/sa-Bc-10	Cepheid	NQX	Class II	2010-07-28
K101826	Hydrofix Vaso Shield, Model Hvs-001-0610	Mimedx Group, Inc.	OMR	Class II	2010-07-28
K101678	Romeo Posterior Osteosynthesis System	Spineart SA	MNH	Class II	2010-07-28
K101615	Powerwire Radiofrequency Guidewire	Baylis Medical Co., Inc.	PDU	Class II	2010-07-28
K101322	Joinsoon Electronics Mfg Co., Ltd Infrared Ear Thermometer, Model Tt-001	Joinsoon Electronics Mfg Co, Ltd.	FLL	Class II	2010-07-28
K101295	Mropen	Paramed S.r.l.	LNH	Class II	2010-07-28
K101276	Derma+flex Qs High Viscosity Tissue Adhesive Model: Qs70404	Chemence Medical Products, Inc.	MPN	Class II	2010-07-28
K100411	Various Dental Implants	Grundy Advanced Biomedical Systems, LLC	DZE	Class II	2010-07-28
K093926	Firebird Spinal Fixation System	Blackstone Medical, Inc.	NKB	Class II	2010-07-28
K093664	Amphetamines II Assay	Roche Diagnostics GmbH	DKZ	Class II	2010-07-28