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 1408 of 3531

510(k) clearances, page 1408 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K033251	The Friendlylight Nd: Yag Lasers	Innotech USA, Inc.	GEX	Class II	2004-03-02
K032330	CT Oia	Thermo Biostar, Inc.	LJC	Class I	2004-03-02
K023342	Neuro-Trace III Kit, Neuro-Trace III Regional Block Cable, Neuro-Trace III Nerve Mapping Probe, Neuro-Trace III Nerve Bg	Hdc Corp.	KOI	Class II	2004-03-02
K040372	Lightspeed 7.0 CT Scanner System	GE Healthcare	JAK	Class II	2004-03-01
K040356	Kompressor Screw System	Kinetikos Medical, Inc.	HWC	Class II	2004-03-01
K040338	Arthrocare Controller, Cable, Foot Control, Power Cord, Wands, Models H0970-02, H2000-04, H2000-05, H0970-06	ArthroCare Corporation	GEI	Class II	2004-03-01
K040304	Philips Intellivue Patient Monitor, Models Mp40 & Mp50	Philips Medizin Systeme Boeblingen GmbH	MHX	Class II	2004-03-01
K040278	Perioglas-Bioglass Bone Graft Substitute	Novabone Products, LLC	LYC	Class II	2004-03-01
K040232	Lsi Sew-Right R Series Suture Placement Device and Access Product Sew-Right Sr-5R, Model 020999	Lsi Solutions Inc.	GAT	Class II	2004-03-01
K040100	Arrow Echogenic Introducer Needle	Arrow Intl., Inc.	DQX	Class II	2004-03-01
K040023	Capiox Flexible Venous Reservoir	Terumo Cardiovascular Systems Corporation	DTN	Class II	2004-03-01
K034049	Herador Ec, Pf, C, H, Nh, G, Gg and Mp; Heraloy U and G; Herabond N; Albabond C, B and a; Bio Heranorm	Kulzer GmbH	EJT	Class II	2004-03-01
K033995	3.5 Mm Lcp Distal Humerus System	Synthes (USA) Products LLC	KTT	Class II	2004-03-01
K033975	Synthes 2.4 Mm Titanium (Ti.) Locking Screws	Synthes (USA) Products LLC	HWC	Class II	2004-03-01
K033948	Microscan Dried Gram-Negative Mic/combo Panels (Gemifloxacin)	Siemens Healthcare Diagnostics Inc.	LRG	Class II	2004-03-01
K033814	Bard Soft Mesh, Models 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007	C.R. Bard Inc	FTL	Class II	2004-03-01
K033792	Bilok St Screw	Biocomposites, Ltd.	HWC	Class II	2004-03-01
K033783	Imalux Oct Imaging System	Imalux Coporation	NQQ	Class II	2004-03-01
K033764	Sp Newtron Module	Satelec	ELC	Class II	2004-03-01
K033617	Eecp Therapy System Model Ts4 With/without Pluse Oximetry	Vasomedical, Inc.	DRN	Class II	2004-03-01
K033616	Trapmatic System Set	H.S. Hospital Service S.p.A.	KNW	Class II	2004-03-01
K033378	Vital Signs Monitor, Propaq Lt	Welch Allyn Protocol, Inc.	MWI	Class II	2004-03-01
K033150	Art Posterior Spinal System	Advanced Medical Technologies AG	MNI	Class II	2004-03-01
K032986	Clo-Surplusp.a.d.	Scion Cardio-Vascular, Inc.	QSY	Unclassified	2004-03-01
K032675	Bd Phoenix Automated Microbiology System-Cefepime (Gn) 0.5-65 Ug/ml	Becton Dickinson & Co	LON	Class II	2004-03-01
K032610	Modified Sonamet Body Composition Analyzer	Life Measurement, Inc.	OAC	Class II	2004-03-01
K031961	Inion Otps Biodegradable Mesh Plating System	Inion Oy	HRS	Class II	2004-03-01
K023684	Cannulated Metallic Hemi Toe Implant, Models Mpj241975, Mpj221775, Mpj211675, Mpj191565, Mpj171365	Vilex, Inc.	KWD	Class II	2004-03-01
K040409	Larsen & Toubro Limited Senorita Color Doppler Ultrasound System	Larsen & Toubro Limited	IYN	Class II	2004-02-27
K040275	Lyphochek Hemostasis Control	Bio-Rad	GGN	Class II	2004-02-27
K040211	Modification to: Collagen Topical Wound Dressing	Collagen Matrix, Inc	KGN	Unclassified	2004-02-27
K040207	Ep-4 Clinical Stimulator	Abbott Medical	JOQ	Class II	2004-02-27
K040192	On-Board Imager Device	Varian Medical Systems, Inc.	IYE	Class II	2004-02-27
K040129	Tri-Ex Extraction Balloon with Multiple Sizing	Wilson-Cook Medical Inc.	GCA	Class II	2004-02-27
K040032	Central Station, Version 3.3H	Hommed, LLC	DXN	Class II	2004-02-27
K040006	Bd Phoenix Automated Microbiology System-Linezolid-Gram Positive	Becton Dickinson & Co	LON	Class II	2004-02-27
K034027	Kls Martin 3Dx External Distraction System	KLS-Martin L.P.	MQN	Class II	2004-02-27
K033879	Validate Tdm Calibration Verification Test Set, Model 126	Maine Standards Co.	DKB	Class II	2004-02-27
K033802	Athena Multi-Lite Rheumatoid Factor Igm Test System	Zeus Scientific LLC	DHR	Class II	2004-02-27
K033786	Luminescent Immunoassay Kit for the Detection of Testosterone in Serum and Saliva	Ibl GmbH	JIT	Class II	2004-02-27
K033771	Bio-Detek Modified Adult Multi-Function Electrode with Connector	ZOLL Medical Corporation	MKJ	Class III	2004-02-27
K033728	Transvaginal Endoscopy Set	Karl Storz Endoscopy-America, Inc.	HEW	Class II	2004-02-27
K033697	Power LED	Dental Products of USA, Inc.	EBZ	Class II	2004-02-27
K033330	Conductivity/tds Calibrator Solution	Mesa Laboratories Inc	FKH	Class II	2004-02-27
K033278	Randox Uric Acid	Randox Laboratories, Limited	CDO	Class I	2004-02-27
K032843	Nexiva Closed IV Catheter System	Becton Dickinson Infusion Therapy Systems Inc.	FOZ	Class II	2004-02-27
K032421	Ambu Pediatric Multi-Function Defibrillation Electrode	Ambu, Inc.	MKJ	Class III	2004-02-27
K020078	Exactech Resorbable Bone Paste	Exactech, Inc.	MQV	Class II	2004-02-27
K040252	Cleaner Rotational Thrombectomy System Kit	Rex Medical LP	MCW	Class II	2004-02-26
K040201	Modification to Burr Hole Valve and Shunt System	Integra Neurosciences Implants S.A.	JXG	Class II	2004-02-26