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 1522 of 3531

510(k) clearances, page 1522 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K021279	Datex-Ohmeda S/5 Anesthesia Monitor with L-Ane02 and L-Ane02a Software	GE Healthcare	MHX	Class II	2002-07-19
K020910	Subdermal Needle Electrode for Electroencephalography, Models Pro-E12saf and Den-12Saf	The Electrode Store	GXZ	Class II	2002-07-19
K014256	Kolibri Igs Systems	Brainlab, Inc.	HAW	Class II	2002-07-19
K013420	Chemwell, Also Known as Project 2900	Awareness Technology, Inc.	JLW	Class II	2002-07-19
K011591	Esophageal Z-Stent with Dua Anti-Reflux Valve	Wilson-Cook Medical Inc.	ESW	Class II	2002-07-19
K022165	Theralight Uv120-2 Uva/uvb Phototherapy System, Model Uv120-2	Theralight, LLC	FTC	Class II	2002-07-18
K022015	Modification to Vertex Reconstruction System	Medtronic Sofamor Danek	KWP	Class II	2002-07-18
K021991	Magnaflow Magnetically Guided Enteral Feeding Tube	Syncro Medical Innovations, Inc.	KNT	Class II	2002-07-18
K021990	Galt Medical Guidewire	Galt Medical Corp	DQX	Class II	2002-07-18
K021809	V-2100G Advanced Infant Incubator	Atom Medical Corporation	FMZ	Class II	2002-07-18
K021326	Vidas Testosterone (Tes), Model 30 418	bioMerieux, Inc.	CDZ	Class I	2002-07-18
K021275	Micomed Posterior Doublerod System	Micomed Ortho GmbH	MNI	Class II	2002-07-18
K020409	Steamplus Sterilization Test	Spsmedical Supply Corp.	JOJ	Class II	2002-07-18
K013926	Qizhou Acupuncture Needle	Wujiang City Shenli Medical and Health Material Co	MQX	Class II	2002-07-18
K012574	Reprocessed Femoral Compression Device	Sterilmed Inc	NMF	Class II	2002-07-18
K021967	Hedrocel Vertebral Body Replacement, Models 06-112-00Xx2 and 06-132-10Xx2	Implex Corp.	MQP	Class II	2002-07-17
K021851	Digital Clinical Thermometer, Model Kd-193	K-Jump Health Co., Ltd.	FLL	Class II	2002-07-17
K021778	Philips Component Compact Monitor, Release A.04, Model #M1275b	Philips North America LLC	DQA	Class II	2002-07-17
K021636	Albumin Reagent	Intersect Systems, Inc.	CJW	Class II	2002-07-17
K021526	Acon Tca One Step Tricyclic Antidepressant Test Strip and Device	Acon Laboratories, Inc.	LFG	Class II	2002-07-17
K021383	Zeodyne Toothbrush with Agion Antimicrobial	Agion Technologies, LLC	EFW	Class I	2002-07-17
K021321	Wrist Fusion Plate	Acu Med, Inc.	HRS	Class II	2002-07-17
K021280	Inion Hexalon Biodegradable Acl/pcl Screw	Inion Oy	HWC	Class II	2002-07-17
K021254	Lactosorb Mini Interference Screw	Biomet Orthopedics, Inc.	HWC	Class II	2002-07-17
K021236	Surgery and Accessories	Camtronics, Ltd.	LLZ	Class II	2002-07-17
K020616	Bayer Rapidpoint 405 System	Bayer Diagnostics Corp.	GKR	Class II	2002-07-17
K020413	Microscan Synergies Plus Dried Gram Negative Mic/combo Panels with Ceftazidime (1-16 Ug/ml)	Siemens Healthcare Diagnostics Inc.	LON	Class II	2002-07-17
K013906	Hls Noetos System	TORNIER Inc.	JWH	Class II	2002-07-17
K022152	Heartwave Alternans Processing System, Model Aps	Cambridge Heart, Inc.	DPS	Class II	2002-07-16
K022149	Cardiac Diagnostic System, Model Ch2000	Cambridge Heart, Inc.	DPS	Class II	2002-07-16
K022083	Human Igg Subclass Kit for Use on the Beckman Immage Analyser	The Binding Site	CFN	Class II	2002-07-16
K022041	Lyphochek Whole Blood Control, Models 561, 562, 563	Bio-Rad Laboratories Inc.	JJY	Class I	2002-07-16
K022013	Lungcare CT Software Package	Siemens Medical Solutions USA, Inc.	JAK	Class II	2002-07-16
K021849	Tagg Disposable Vaginal Speculum	Tagg Industries	HIB	Class II	2002-07-16
K021839	Aart Gluteal Implant	Aesthetic and Reconstructive Technologies, Inc.	MIB	Class II	2002-07-16
K021820	Aart Silicone Carving Block	Aesthetic and Reconstructive Technologies, Inc.	MIB	Class II	2002-07-16
K021736	Bard Ventralex Hernia Patch, Models 0010302, 0010301	C.R. Bard Inc	FTL	Class II	2002-07-16
K021515	Easystat Ph, Pco2, Po2, Hct, Na+, K+, Ca++ Analyzer	Medica Corp.	CHL	Class II	2002-07-16
K021512	Cobas Integra Online Dat II Methadone II	Roche Diagnostics GmbH	DJR	Class II	2002-07-16
K021505	Online Dat II Methadone II	Roche Diagnostics GmbH	DJR	Class II	2002-07-16
K021438	Insemination Catheter, Model 320301	Labotect Labor-Technik Gottingen	MFD	Class II	2002-07-16
K021356	The Divacup Menstrual Solution	Diva International, Inc.	HHE	Class II	2002-07-16
K020005	Infant Feeding Tubes	Promedic, Inc.	KNT	Class II	2002-07-16
K014246	Avid-Nit Nerve Stimulation Needles	Avid N.I.T., Inc.	CAZ	Class II	2002-07-16
K013843	Autoset Spirit CPAP System	ResMed Corp	BZD	Class II	2002-07-16
K012437	Devilbiss Sleep Recorder Model # Rm60	Sunrise Medical Hhg, Inc.	MNR	Class II	2002-07-16
K012018	Bicap Coag Bipolar Laparoscopy Probe, Model 006908-910	Acmi Corporation	GEI	Class II	2002-07-16
K022038	Spi Onetime Dental Implant	Paxmed International, LLC	DZE	Class II	2002-07-15
K021592	Phfw-10	Pihsiang Machinery Mfg. Co., Ltd.	ITI	Class II	2002-07-15
K021520	Emt-CPAP	Emergency Medical Techology	BTL	Class II	2002-07-15