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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 845 of 3530

510(k) clearances, page 845 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K123964	Axsos 3 Ti Locking Plate System	Stryker Trauma GmbH	HRS	Class II	2013-03-28
K123624	Otostat Dpoae + Mepa Measurement System	Mimosa Acoustics, Inc.	EWO	Class II	2013-03-28
K123512	Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 Mm	Biodenta Swiss AG	DZE	Class II	2013-03-28
K123338	Barricade Embolization Coil System	Blockade Medical	HCG	Class II	2013-03-28
K123272	1.5T 16Ch Flex Speeder Large, 1.5T 16Ch Flex Speeder Medium	NeoCoil, LLC	MOS	Class II	2013-03-28
K123178	Stryker Venom Electrodes and Cannulae	Stryker Corp.	GXI	Class II	2013-03-28
K123139	Advanced Endodontic System- Designer Series	ASI Medical, Inc.	ELC	Class II	2013-03-28
K123100	Intess Lumbar Cage	Kalitec Direct, LLC	MAX	Class II	2013-03-28
K122850	Talos-C Cervical Intervertebral Body Fusion Devices	Meditech Advisors, LLC	ODP	Class II	2013-03-28
K122770	Biomet Reconstructive Wedges Model 110003660-99, 110003797-831	Biomet Manufacturing Corp	HRS	Class II	2013-03-28
K122744	Prospera OTC TENS Electronic Pulse Massager	Prospera Corporation	NUH	Class II	2013-03-28
K122272	Cardiomem	Getemed Medizin- und Informationstechnik AG	MWJ	Class II	2013-03-28
K122175	Mendec Spine Hv, Mendec Spine Hv System	Tecres SpA	NDN	Class II	2013-03-28
K121743	Easymed Peripheral Nerve Stimulator-Sunstin	Sunmed, Inc.	BXN	Class II	2013-03-28
K124029	Microline Flexible Ligating Shears	Microline Surgical, Inc	GEI	Class II	2013-03-27
K123870	Xpeed Anyridge Internal Implant System	Megagen Implant Co., Ltd.	DZE	Class II	2013-03-27
K123859	Tbd	LENSAR, Inc	OOE	Class II	2013-03-27
K123762	Dlp Retrograde Coronary Sinus Perfusion Cannula with Auto-Inflate Cuff	Medtronic, Inc.	DWF	Class II	2013-03-27
K122494	Posisep and Posisep X Hemostat Dressing/intranasal Splint	Hemostasis, LLC	LYA	Class I	2013-03-27
K122480	International Biophysics Corporation Afflovest	International Biophysics Corp.	BYI	Class II	2013-03-27
K121823	Clinical Chloride Analyzer, Chloride Test System, Sweat Chloride Analyzer, Chloridometer, Chloride Coulometric	ELITechGroup Inc	JFS	Class II	2013-03-27
K113823	Hevylite Human Igm Kappa and Hevylite Igm Lambda Kit	The Binding Site Group Ltd.	CFN	Class II	2013-03-27
K130671	Venacure Evlt Nevertouch Procedure Kit	Boston Scientific Corporation	GEX	Class II	2013-03-26
K130415	High Metabolite Qualicheck	Radiometer Medical ApS	JJS	Class I	2013-03-26
K123976	Nobelclinician	Nobel Biocare AB	LLZ	Class II	2013-03-26
K123743	Ultrasafe Plus Passive Needle Guard	Safety Syringes, Inc.	MEG	Class II	2013-03-26
K123118	Insignia Digicast	Ormco Corp.	DYW	Class II	2013-03-26
K122560	Versalvent Model V1 Hyperbaric Chamber Ventilator Model V1	Pan-America Hyperbarics, Inc.	CBK	Class II	2013-03-26
K122362	Smart-Well Incubator	Mesa Laboratories Inc	FRC	Class II	2013-03-26
K130754	Acuson Sc2000 Diagnostic Ultrasound System	Siemens Medi Cal Solutions, Inc.	IYN	Class II	2013-03-25
K130396	Rampart O and Rampart P	Spineology, Inc.	MAX	Class II	2013-03-25
K130173	Sonosite Maxx Series Ultrasound System	FUJIFILM SonoSite,Inc.	IYN	Class II	2013-03-25
K124059	Aquaboss Ecoro Dia I (Ht); Aquaboss Ecoro Dia II (Ht)	Lauer Membran Wassertechnik GmbH	FIP	Class II	2013-03-25
K123745	Sp2 Femoral Locking Nail, Sp2 Tibial Locking Nail	Biomecanica Industria E Comerico de Productos Orto	HSB	Class II	2013-03-25
K123665	Lifelines Ieeg	Kvikna Ehf	OLT	Class II	2013-03-25
K113871	Pro-Dense Bone Graft Substitute	Wrightmedicaltechnologyinc	MQV	Class II	2013-03-25
K130164	Fiberlase Endure CO2 Fiber	Lumenis Ltd	GEX	Class II	2013-03-24
K123618	Axera 2 Access System	Arstasis, Inc.	DYB	Class II	2013-03-24
K122584	Hemosil Readiplas Tin	Instrumentation Laboratory Co.	GJS	Class II	2013-03-24
K130596	Caiman Seal and Cut Technology	Aesculap Inc	GEI	Class II	2013-03-22
K130276	Dimension Exl with Lm System	Siemens Healthcare Diagnostics Inc.	JJE	Class I	2013-03-22
K130141	S Test Reagent Cartridge Alp (Alkaline Phosphatase)	Canon Medical Diagnostics USA, Inc.	CJE	Class II	2013-03-22
K130009	Variax 2 Compression Plating System	Stryker Trauma GmbH	HRS	Class II	2013-03-22
K124004	Navigated Cd Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy Taps	Medtronic Navigation, Inc	OLO	Class II	2013-03-22
K123652	Spineology Peek Lumbar Interbody Fusion Device	Spineology, Inc.	MAX	Class II	2013-03-22
K123587	Heine Mini 3000 LED Ophthalmoscope	Heine Optotechnik GmbH & Co. KG.	HLJ	Class II	2013-03-22
K123556	Mortara Surveyor Patient Monitor	Mortara Instrument, Inc.	MHX	Class II	2013-03-22
K123457	Balanced Knee System High Flex Ps	Ortho Development Corp.	JWH	Class II	2013-03-22
K123303	Femoral Access Venous Cannulae	Edwards Lifesciences LLC	DWF	Class II	2013-03-22
K123013	Endoscopic Introducer	Novadaq Technologies ULC	FED	Class II	2013-03-22