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 1349 of 3531

510(k) clearances, page 1349 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K041879	Palomar Lux1064 Handpiece	Palomar Medical Technologies, Inc.	GEX	Class II	2005-01-13
K041736	Pfa Patch	Peritec Biosciences, LLC	DXZ	Class II	2005-01-13
K041717	Powerstick Male Latex Condoms	A.P.Deauville, LLC	HIS	Class II	2005-01-13
K041667	San-Mar Labs Lubricating Jelly	San-Mar Laboratories, Inc.	HIS	Class II	2005-01-13
K041086	Palomar Starlux Pulsed Light System	Palomar Medical Products, Inc.	GEX	Class II	2005-01-13
K043559	Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)	FUJIFILM SonoSite,Inc.	IYN	Class II	2005-01-12
K043473	Modification to Xia Spinal System	Howmedica Osteonics Corp	KWP	Class II	2005-01-12
K043468	Willi Geller Creation II Porcelain	Jensen Int'L, Inc.	EIH	Class II	2005-01-12
K043437	Full Automatic (Nibp) Blood Pressure Monitor, Model Hl168et	Health & Life Corporation	DXN	Class II	2005-01-12
K043429	Cynergy Laser	Cynosure, LLC	GEX	Class II	2005-01-12
K043427	Duragen II Dural Regeneration Matrix	Integra LifeSciences Corporation	GXQ	Class II	2005-01-12
K043422	Asahi Ptca Guide Wire, J Shape Series	Asahi Intecc Co., Ltd.	DQX	Class II	2005-01-12
K043395	Smith & Nephew Videoarthroscope	Smith & Nephew, Inc.	HRX	Class II	2005-01-12
K043262	Ge Signa Excite Mr Surgical Option	GE Healthcare	LNH	Class II	2005-01-12
K043129	Proclear Ultravue Multifocal and Proclear Ultravue 2000T Multifocal Toric (Omaflicon a) Soft (Hydrophilic Contact Lens)	Opti-Centre Laboratories	LPL	Class II	2005-01-12
K043009	Brainet Kit	Jordan Neuroscience, Inc.	GXY	Class II	2005-01-12
K042993	Triathlon Posteriorly Stabilized (Ps) Femoral Component	Howmedica Osteonics Corp	JWH	Class II	2005-01-12
K042896	Smith & Nephew Hybrid Knee Femoral	Smith & Nephew, Inc.	NPJ	Class II	2005-01-12
K042861	Odyssey	Optivus Proton Therapy, Inc.	MUJ	Class II	2005-01-12
K042217	Flowmedic, Model 220	Flowmedic (Israel), Ltd.	JOW	Class II	2005-01-12
K034026	Rt 138 & Rt 141 Dual-Heated Neonatal Breathing Circuits	Fisher & Paykel Healthcare, Inc.	BZE	Class II	2005-01-12
K043563	Dp-9900 Digital Ultrasonic Diagnostic Imaging System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYO	Class II	2005-01-11
K043462	Czr Press Lf	Noritake Co., Inc.	EIH	Class II	2005-01-11
K043456	Modification to Soaker Catheter	Halyard Health	BSO	Class II	2005-01-11
K043201	Willi Geller Creation Zi Porcelain	Jensen Industries, Inc.	EIH	Class II	2005-01-11
K043194	Voxar 3D Product Family	Voxar Limited	LLZ	Class II	2005-01-11
K042870	Endo Twinn	Endo Twinn B.V.	EKM	Class I	2005-01-11
K042528	Inbody, Model 3.0	Biospace Inc.	MNW	Class II	2005-01-11
K043576	Roche Amplichip Cyp450 Test	Roche Molecular Systems Inc	NTI	Class II	2005-01-10
K043376	Home Health Power Wheelchair, Model Hc-200Tr	Home Health Technology Co., Ltd.	ITI	Class II	2005-01-10
K043354	Modular Telemetry System for the Vision Telepak, Model 20701	Invivo Research, Inc.	DRT	Class II	2005-01-10
K043305	Online Dat Phencyclidine Plus	Roche Diagnostics GmbH	LCM	Unclassified	2005-01-10
K043043	Hermes Bond 2	3M Espe AG Dental Products	KLE	Class II	2005-01-10
K042657	Vioptix Odissey Tissue Oximeter Tissue Oximeter, Model Oxy-2	Vioptix, Inc.	MUD	Class II	2005-01-10
K042635	Denali Spine System	K2M, Inc	KWP	Class II	2005-01-10
K042624	Amphirion Deep 0.014 Otw Pta Balloon Catheter	Invatec Innovative Technologies, S.r.l.	DQY	Class II	2005-01-10
K042542	Cytovision for Cep Xy	Applied Imaging Corp.	NTH	Class II	2005-01-10
K042184	Goodknight H20, Model M-114600-00	Mallinckrodt Developpement France	BTT	Class II	2005-01-10
K043566	Modification to Verte-Stack Spinal System	Medtronic Sofamor Danek	MQP	Class II	2005-01-07
K043544	Medela Dominant 35 C/i Secretion and Surgical Aspirator	Medela AG	BTA	Class II	2005-01-07
K043477	Powdered Vinyl Patient Examination Gloves, White (Non-Colored)	Shijiazhuang Winful Plastic Co., Ltd.	LYZ	Class I	2005-01-07
K043359	4100 Patient Oximeter Module	Nonin Medical, Inc	DQA	Class II	2005-01-07
K043347	Bf+	Ldr Spine USA	MQV	Class II	2005-01-07
K043208	Liquid Assayed Multiqual Control	Bio-Rad	JJY	Class I	2005-01-07
K043205	Rusch Easy Tube	Teleflex Medical	BTR	Class II	2005-01-07
K043172	Trugraft Bgs Syringe, Model 600-041	Osteobiologics, Inc.	FMF	Class II	2005-01-07
K043047	Dynatron Ibox Iontophoresis Device	Dynatronics Corp.	EGJ	Class II	2005-01-07
K043045	Synthes (USA) Chronos	Synthes (USA) Products LLC	MQV	Class II	2005-01-07
K043028	Emit II Plus Ecstasy Assay	Siemens Healthcare Diagnostics Inc.	DKZ	Class II	2005-01-07
K043020	Glaxy 3.2 Spinal System	Medtronic Sofamor Danek	KWP	Class II	2005-01-07