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 1442 of 3531

510(k) clearances, page 1442 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K031882	Endoscopic Applicator	Baxter Healthcare Corporation	GCJ	Class II	2003-09-05
K031772	Ti Fenestrated Plate	Interpore Cross Intl.	KWP	Class II	2003-09-05
K031764	Oncor Avant-Garde with Coherence Workspaces	Siemens Medical Solutions USA, Inc.	IYE	Class II	2003-09-05
K023354	Compressor Mini, 115 V, Model 64 81 779 Eh81e	Siemens Elema AB	BTI	Class II	2003-09-05
K032493	Alexander	Ivoclar Vivadent, Inc.	EJT	Class II	2003-09-04
K032491	Ecom Cv4 Endotracheal Cardiac Output Monitor	Imagyn Medical Technologies, Inc.	DSB	Class II	2003-09-04
K032479	Howmedica Osteonics Tibial Tray Screw Hole Plugs	Howmedica Osteonics Corp	JWH	Class II	2003-09-04
K032457	Modification to Smart Control Nitinol Stent Transhepatic Biliary System	Cordis US Corp.	FGE	Class II	2003-09-04
K032136	Wirobond C	Bego U.S.A.	EJH	Class II	2003-09-04
K032037	Cd Horizon (Addition of Spinous Process Plate)	Medtronic Sofamor Danek	MNI	Class II	2003-09-04
K032032	Synthes (USA) Lcp Proximal Femur Hook Plates	Synthes (USA) Products LLC	HRS	Class II	2003-09-04
K031937	Alantech Graft Fixation Screw	ArthroCare Corporation	HWC	Class II	2003-09-04
K031919	Ebi Xfix Dfs System	Ebi, LLC	KTT	Class II	2003-09-04
K031857	Advia Chemistry Alpha-1 Antitrypsin Assay	Bayer Diagnostics Corp.	DEM	Class II	2003-09-04
K031811	Pit & Fissure Sealant with Fluoride	Harry J. Bosworth Co.	EBC	Class II	2003-09-04
K031785	Macropore Cardio-Wrap (Ts)	Macropore Biosurgery, Inc.	OMH	Class II	2003-09-04
K031315	Tmc Electrical Scooter, Easy 321	Tmc Technology Corp.	INI	Class II	2003-09-04
K031314	Tmc Electrical Scooter, Easy 411	Tmc Technology Corp.	INI	Class II	2003-09-04
K031313	Tmc Electrical Scooter, Easy 405	Tmc Technology Corp.	INI	Class II	2003-09-04
K030629	Dolphin Medical 2150 Handheld Pulse Oximeter	Dolphin Medical, Inc.	DQA	Class II	2003-09-04
K032622	Attain Prevail Left Heart Delivery System Moddel, 6228Sys	Medtronic, Inc.	DQY	Class II	2003-09-03
K032345	Cyberknife System for Sterotactic Radiosurgery/radiotherapy	Accuray Incorporated	MUJ	Class II	2003-09-03
K032173	Femtex and Private Label Scented Plastic Applicator Tampons	First Quality Hygienic, Inc.	HIL	Class II	2003-09-03
K032012	Homocysteine Microtiter Plate Assay	Diazyme Laboratories, Inc.	LPS	Class II	2003-09-03
K031833	Modification to Cd Horizon Spinal System	Medtronic Sofamor Danek	MNI	Class II	2003-09-03
K031761	Synthes (USA) New/sterial Orbital Plates	Synthes (USA) Products LLC	JEY	Class II	2003-09-03
K031691	Merit Mak (Mini Access Kit)	Merit Medical Systems, Inc.	DRE	Class II	2003-09-03
K030662	Pathway Access Sheath Catheter	Vertelink Corporation	EZN	Class II	2003-09-03
K030652	Medro Spd	Usfilter/Ionpure, Inc.	FIP	Class II	2003-09-03
K030630	Edwards Directional Catheter	Edwards Lifesciences LLC	DQY	Class II	2003-09-03
K032545	Endoscopic Light Source Ls-3000X; Ls-1800Xg/med Light X 180; Ls-2500H/med Light H 250	Mgb Endoskopische Gerate GmbH (Berlin)	FET	Class II	2003-09-02
K032544	Vp-1000; Med Cam 100; Vp-3000A; Med Cam 300	Mgb Endoskopische Gerate GmbH (Berlin)	FET	Class II	2003-09-02
K032156	Accufix Radiolucent Pelvis and Belly Boards, Accufix Cantilever Head Board with Shoulder Depression, Accufix Radiolucent	Anholt Technologies Inc.	IYE	Class II	2003-09-02
K032022	Digital Imager	Pyramid Medical, Inc.	LMA	Class II	2003-09-02
K032020	51Cm(20.1inch) Tft Monochrome Lcd Monitor, Mu5111bw	Iiyama Corporation	LLZ	Class II	2003-09-02
K031758	Acmi M4 Telescopes	Acmi Corporation	FBP	Class II	2003-09-02
K031739	I-Stat Cardiac Troponin (Ctni) Test	I-Stat Corp.	MMI	Class II	2003-09-02
K031729	Triathlon Posteriorly Stabilized (Ps) Total Knee System	Howmedica Osteonics Corp	JWH	Class II	2003-09-02
K030633	Medtronic Ave Bridge Constant Biliary Stent System or ('Constant	Medtronic, Inc.	FGE	Class II	2003-09-02
K030553	Arkit Hba1c	Arkray, Inc.	LCP	Class II	2003-09-02
K030328	Vidas D-Dimer New (Dd2) Assay, Model 30 442	bioMerieux, Inc.	DAP	Class II	2003-09-02
K023722	Safetywand Disposable Handpiece	Spintech, Inc.	EJI	Class II	2003-09-02
K032579	S2 Nail System	Howmedica Osteonics Corp	HSB	Class II	2003-08-29
K032526	Binder CO2 Incubator Serie Cb	Binder GmbH	MQG	Class II	2003-08-29
K032409	Vitoss Scaffold Synthetic Cancellous Bone Void Filler	DSM Biomedical, Inc.	MQV	Class II	2003-08-29
K032390	Modification to Ebi Targetcath Fluoro-Guided Steerable Catheter System	Ebi, LLC	BSO	Class II	2003-08-29
K032382	Sensititre Haemophilus/streptococcus Pneumoniae (Hp) Mic Plates	Trek Diagnostic Systems, Ltd.	JWY	Class II	2003-08-29
K032256	Quasar-Quasar Plus-Quasar Toric (Hybufocon a, Hexafocon a, Paflufocon B) Rigid Gas Permeable (Rgp) Daily Wear Contact Le	No 7 Contact Lens Laboratory, Ltd.	LPL	Class II	2003-08-29
K032254	Ibl C1q-Cic Cia Test	Ibl GmbH	DAK	Class II	2003-08-29
K032213	Stockert Centrifugal Pump System with Tubing Clamp	Stockert Instrumente GmbH	DWA	Class II	2003-08-29