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 1804 of 3531

510(k) clearances, page 1804 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K973244	Active Psa Irma (Dsl-9700)	Diagnostic Systems Laboratories, Inc.	LTJ	Class II	1998-08-03
K973243	Active Psa Elisa (Dsl-10-9700)	Diagnostic Systems Laboratories, Inc.	LTJ	Class II	1998-08-03
K982664	Vita Titanium Porcelain	Vident	EIH	Class II	1998-08-02
K982513	Mx Mevatron	Siemens Medical Solutions USA, Inc.	IYE	Class II	1998-07-31
K982502	Genesis Imrt Linear Accelerator	Siemens Medical Solutions USA, Inc.	IYE	Class II	1998-07-31
K982421	Imagyn 125 I Seed, Model Is 125	International Isotopes, Inc.	IWG	Class II	1998-07-31
K982368	Manifold with Extension Set	Interpore Cross Intl.	FMG	Class II	1998-07-31
K982302	Implex Continuum Knee - Hedrocel Tibial Spacers	Implex Corp.	JWH	Class II	1998-07-31
K982148	Prodigy 2	Sybron Dental Specialties, Inc.	EBF	Class II	1998-07-31
K981959	Outlook Large Phased Array Neck Coil	Philips North America LLC	MOS	Class II	1998-07-31
K981889	Worldwide Medical Technologies Introducer Needle	Worldwide Medical Technologies, LLC	FCG	Class II	1998-07-31
K981713	Cicanet Wound Contact Layer Dressing - 2 X 3 in. Model 59100600, Cicanet Wound Contact Layer Dressing - 4 X 5 in. Model0	Smith & Nephew, Inc.	MGP	Unclassified	1998-07-31
K981627	Protege II Er: Yag Laser System and Accessoies (Upgrade)	Xintec Corporation	GEX	Class II	1998-07-31
K981620	Mta Material II	Dentsply Intl.	KIF	Class II	1998-07-31
K981596	Ultrapak E	Ultradent Products Inc.	MVL	Unclassified	1998-07-31
K981397	Harmonic Imaging and Flash Echo Imaging Function for the Diagnostic Ultrasound System Ssa-380A, Powervision 7000	Toshiba America Medical Systems, In.C	IYN	Class II	1998-07-31
K980990	Polycarboxylate Cement	Medental Intl.	EMA	Class II	1998-07-31
K980719	Calm	PeriGen Solutions Ltd.	HGM	Class II	1998-07-31
K980536	Epidural Needle	Argon Medical Devices, Inc	BSP	Class II	1998-07-31
K974707	Imagequest	Visual Med, Inc.	LMD	Class I	1998-07-31
K982341	Direct Hdl-Cholestrol Liquid	Randox Laboratories, Limited	LBS	Class I	1998-07-30
K982282	Dura-Guard - Dural Repair Patch	Bio-Vascular, Inc.	GXQ	Class II	1998-07-30
K982235	Pasco Mic and Mic/id Panels	Pasco Laboratories, Inc.	JTN	Class II	1998-07-30
K982041	Uibc	Abbott Medical	JMO	Class I	1998-07-30
K981815	Heptrac Electronic Quality Control	Medtronic Blood Management	JPA	Class II	1998-07-30
K981611	Snap-N-Peel Introducers	Circon Corp.	KNY	Class II	1998-07-30
K981589	Electrosurgical Basket Electrodes Electrosurgical Basket Electrodes	Conway Stuart Medical, Inc.	GEI	Class II	1998-07-30
K981562	Spline Dental Implant System - Spline XI Implant	Sulzer Calcitek, Inc.	EBF	Class II	1998-07-30
K981396	Pyloriprobe	Amdl, Inc.	LYR	Class I	1998-07-30
K980821	Helicobacter Pylori Igg Elisa Test System	Zeus Scientific LLC	LYR	Class I	1998-07-30
K980573	Sensorex Blood Glucose Monitoring System	Chronimed, Inc.	CGA	Class II	1998-07-30
K974428	Dipstreak	Novamed Co., Ltd.	JSI	Class I	1998-07-30
K972913	Macropore Protective Sheet (Protego System)	Pacific Materials and Interfaces	HRS	Class II	1998-07-30
K982443	Doc Ventral Cervical Stabilization System	Depuy Motech Acromed	KWQ	Class II	1998-07-29
K982351	Luna	Stellate Systems	OLT	Class II	1998-07-29
K982222	Synthes (USA) Distal Femur Plate (Dfp) System	Synthes (USA) Products LLC	HWC	Class II	1998-07-29
K982211	Profile-II Model 600582	MEDTOX Diagnostics, Inc.	DKE	Class II	1998-07-29
K982156	Pasco Mic and Mic/id Panels/ Cefdinir	Pasco Laboratories, Inc.	JWJ	Class II	1998-07-29
K981941	Multaport Cannula Reducer and Accessories	Dexide, Inc.	GCJ	Class II	1998-07-29
K981857	Quanta Lite Tpo Elisa	Inova Diagnostics, Inc.	LLL	Class II	1998-07-29
K981856	Magna-Cam (Mr Endoscopic Camera) and Magna-Pix ( Mr Color Video Monitor)	Greatbatch Scientific	FET	Class II	1998-07-29
K981821	Ves 3001/2 Dual Output Video Illuminator	Angiolaz, Inc.	FSS	Class II	1998-07-29
K981794	Hichem Calcium Reagent Kit	Hichem Diagnostics	CJY	Class II	1998-07-29
K981775	Depuy Ace Timax Calcaneal Peri-Articular Plate	Depuy Ace Medical Co.	HRS	Class II	1998-07-29
K981715	Distal Radius Fracture Fixation Plate	Avanta Orthopaedics, Inc.	HRS	Class II	1998-07-29
K980962	Brennen Medical Beta Glucan Cream, Macropro	Brennen Medical, Inc.	MGQ	Unclassified	1998-07-29
K980389	Megabeam Reusable Fiber Optic Handpiece and Needles	Ceram Optec, Inc.	GEX	Class II	1998-07-29
K980288	Spine-Tech Silhouette Spinal Fixation System	Spine-Tech, Inc.	KWP	Class II	1998-07-29
K974111	Quidel Ch50 Eq Eia	Ortho-Clinical Diagnostics, Inc.	DAE	Class II	1998-07-29
K973980	Acu-Stim TENS, Ap-101082T	Apex Medical, Inc.	GZJ	Class II	1998-07-29