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 1398 of 3531

510(k) clearances, page 1398 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K040537	Ams Apogee Vault Suspension System	American Medical Systems, Inc.	OTP	Class III	2004-04-22
K040495	Naimco, Inc., Iontophoresis Drug Delivery Electrodes, Models 201-400, 201-401, 201-402, 201-403 and 201-405	Naimco, Inc.	EGJ	Class II	2004-04-22
K040396	Ultrasonic Scaler Elegance Ms-10 (25K)	Rolence Enteprise, Inc.	ELC	Class II	2004-04-22
K040259	Masimo Set Intellivue Pulse Oximeter Module	Masimo Corporation	DQA	Class II	2004-04-22
K040148	Resolution Hemostasis Clipping Device	Boston Scientific Corporation	MCH	Class II	2004-04-22
K033914	Oxygen Diverter Valve	ResMed Corp	BZD	Class II	2004-04-22
K033727	Nichols Advantage Bio-Intact Pth (1-84) Immunoassay	Nichols Institute Diagnostics	CEW	Class II	2004-04-22
K033699	Locator Bar Female, Locator Laser Bar Female, Locator Bar Cast-to Female, Models 08587, 08588, 08586	Zest Anchors LLC	DZE	Class II	2004-04-22
K033534	Vitalsense	Mini-Mitter Co., Inc.	FLL	Class II	2004-04-22
K032981	Sppro Esp, Models Esp 603-18-05, Esp 603-18-09	Invamed Technologies, Inc.	BSP	Class II	2004-04-22
K030747	Prodose Aad System	Profile Therapeutics PLC	CAF	Class II	2004-04-22
K040910	Infant Incubator, Model Chs-I1000	Choong Wae Medical Corp.	FMZ	Class II	2004-04-21
K040902	Hitachi Presto	FUJIFILM Healthcare Americas Corporation	JAK	Class II	2004-04-21
K040117	Uniport Self-Contained Portable Dental Unit	Arrow Industries, LLC	EIA	Class I	2004-04-21
K034056	Modification to Cd Horizon Spinal System	Medtronic Sofamor Danek	MNH	Class II	2004-04-21
K033630	Modification of: Sphero Flex, Pivot Flex, and Sphero Block	Rhein 83 SRL	DZE	Class II	2004-04-21
K033092	The Gnathometer	Ortho Gnathics, LLC	JEY	Class II	2004-04-21
K040909	Sono Tt Ultrasonic Flowcomputer	Em-Tec GmbH	DPW	Class II	2004-04-20
K040236	Pulpdent Vlc Resin Cement	Pulpdent Corporation	EMA	Class II	2004-04-20
K040235	Licox Pmo Brain Monitoring System	Integra LifeSciences Corporation	GWM	Class II	2004-04-20
K040131	Cooltouch; Cooltouch II; and Cooltouch Ct3 Nd:yag Laser System	New Star Lasers, Inc.	GEX	Class II	2004-04-20
K040116	Hawk Intraoral Camera and Accessories	Dxm Co., Ltd.	EIA	Class I	2004-04-20
K040085	Personal Warming Lubricant	Qualis, Inc.	HIS	Class II	2004-04-20
K033485	Endoscout	Robin Medical, Inc.	LNH	Class II	2004-04-20
K033123	Stratusoct with Rnfl & Macula Normative Database	Carl Zeiss Meditec Inc	HLI	Class II	2004-04-20
K033006	Mivd 1218 18 Inch Greyscale Lcd Display Module	Barco NV Barcoview	LLZ	Class II	2004-04-20
K040940	Bronchovideoscope Olympus Xbf-D160hm	Olympus Corp.	EOQ	Class II	2004-04-19
K040876	Iconnection, Version 3.2.0.0 Medical Image Processing Software	Canon Medical Informatics, Inc.	LLZ	Class II	2004-04-19
K040828	Disposable Powdered Vinyl Patient Examination Gloves	Zibo Borui Plastic & Rubber Products Co., Ltd.	LYZ	Class I	2004-04-19
K040786	Vascupuncture Picc Guidewire with Hydro-Silk Coating	Neometrics, Inc.	DQX	Class II	2004-04-19
K040509	Alta Lr Fixed Tip Chronic Hemodialysis Catheter, Models Al19nh24, Al23nh28, Al27nh32, Al31nh36, Al35nh40	Spire Biomedical, Inc.	MSD	Class II	2004-04-19
K040402	Angiodynamics, Inc. More-Flow Hemodialysis Catheter and Procedure Kit	Boston Scientific Corporation	MSD	Class II	2004-04-19
K040327	Accu-Stat Home Drug Tests for Marijuana (Thc) and for Marijuana & Cocaine (Thc, Coc)	Accu-Stat Diagnostics, Inc.	MVO	Unclassified	2004-04-19
K040126	Viatronix V3d Colon, Revision 1.3	Viatronix, Inc.	LLZ	Class II	2004-04-19
K040125	Senographic Stereo	GE Healthcare	IZH	Class II	2004-04-19
K033104	Mgd 2621P Medical Greyscale Display	Barco NV Barcoview	LLZ	Class II	2004-04-19
K033005	Mfgd 1318 18 Inch 1 Megapixel Greyscale Lcd Display	Barco NV Barcoview	LLZ	Class II	2004-04-19
K030366	Bicard Mixing System	Dialysis Systems, Inc.	FIN	Class II	2004-04-19
K040855	Instrumed Laparoscope and Accessories	Instrumed International Inc dba Avalign German Specialty Instruments	GEI	Class II	2004-04-16
K040707	Packaging Tray and Components	Phoenix Biomedical Corp.	FRG	Class II	2004-04-16
K040622	Freedom Hp	Freedom Designs Inc	IOR	Class I	2004-04-16
K040482	Ebi Esl Spine Spacer System	Ebi, LLC	MQP	Class II	2004-04-16
K040261	Reflex Hybrid Anterior Cervical Plate System	Howmedica Osteonics Corp	KWQ	Class II	2004-04-16
K040163	Microvascular Anastomotic Device	SYNOVIS MICRO COMPANIES ALLIANCE, Inc. (a subsidiary of Baxter International Inc.)	MVR	Class II	2004-04-16
K040068	Biliblanket Plus High Output Phototherapy System	GE Healthcare	FMZ	Class II	2004-04-16
K033871	Im Total Femur	Zimmer GmbH	JDI	Class II	2004-04-16
K033103	Mgd 2621L Medical Greyscale Display	Barco NV Barcoview	LLZ	Class II	2004-04-16
K033004	Mfgd 2320 20 Inch 2 Megapixel Greyscale Lcd Display	Barco NV Barcoview	LLZ	Class II	2004-04-16
K032976	Biovalve Miniject Needle-Free Injection System, Model Fg-01-001	Biovalve Technologies, Inc.	KZE	Class II	2004-04-16
K032806	Katalyst Radial Head Implant	Kinetikos Medical, Inc.	KWI	Class II	2004-04-16