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 1386 of 3531

510(k) clearances, page 1386 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K040316	Cedia Buprenorphine Assay	Microgenics Corporation	DJG	Class II	2004-06-23
K041581	Compacs, Version 1.0	Intelligent Images SRL	LLZ	Class II	2004-06-22
K041543	Ge Discovery St	GE Healthcare	KPS	Class II	2004-06-22
K041521	Volume Viewer Plus	General Electric Medical Systems	JAK	Class II	2004-06-22
K041518	Codman Duraform Dural Graft Implant	Cerenovus, Inc.	GXQ	Class II	2004-06-22
K041369	Navitrack System - S&n Image Free Hip, Model Pro-03017	Orthosoft, Inc.	HAW	Class II	2004-06-22
K041108	Iscience Surgical Ophthalmic Microcannula	Iscience Surgical Corporation	MPA	Class II	2004-06-22
K040911	Vitalheat	Dynatherm Medical, Inc.	DWJ	Class II	2004-06-22
K040894	Qbtest	Qbtech AB	LQD	Unclassified	2004-06-22
K040817	Popspek Disposable Adjustable Vaginal Speculum	Advanced Urological Developments	HIB	Class II	2004-06-22
K040238	Softseal Hsg Catheter	Modern Medical Equipment Mfg., Ltd.	LKF	Class II	2004-06-22
K033464	Edwards Lifesciences Research Medical Pediatric Venous Return Cannulae	Edwards Lifesciences LLC	DWF	Class II	2004-06-22
K031368	Powdered Latex Surgeon's Gloves	Cephas Medical Private, Ltd.	KGO	Class I	2004-06-22
K041500	Starpacs Orthopedics System	Infinitt Co., Ltd.	LLZ	Class II	2004-06-21
K040950	Aloclair Oral Gel	Sinclair Pharmaceuticals Ltd	OLR	Unclassified	2004-06-21
K040853	Phoenix Phototherapy Unit Cfl, Model 101	International Hospital Supply Co.	LBI	Class II	2004-06-21
K040700	Concentric Retriever X5, Model 90035; Concentric Retriever X6, Model 90037	Concentric Medical, Inc.	DQY	Class II	2004-06-21
K040413	Cordis Palmaz Blue Transhepatic Biliary Stent on Slalom .018 Delivery System	Cordis Europa, N.V.	FGE	Class II	2004-06-21
K040187	Medicinal Leeches	Ricarimpex SAS	NRN	Unclassified	2004-06-21
K040135	Thermage Thermacool System	Solta Medical, Inc.	GEI	Class II	2004-06-21
K033868	Synthes (USA) Patient Specific Cranial/craniofacial Implants	Synthes (USA) Products LLC	GXN	Class II	2004-06-21
K041450	Modification to Nico with Mars, Model 7300	Respironics Novametrix, LLC.	CCK	Class II	2004-06-18
K041412	Esprit Ventilator with Nico-Esprit Interface Option, Model V1000	Respironics, Inc.	CBK	Class II	2004-06-18
K041313	Stabil-O-Graph	I.E.M. GmbH	DXN	Class II	2004-06-18
K041303	LED Turbo-Pen	Apoza Enterprise Co., Ltd.	EBZ	Class II	2004-06-18
K041107	Taidoc Check	Taidoc Technology Corporation	NBW	Class II	2004-06-18
K040987	Cryocheck Clot C	Precision BioLogic Inc.	GGP	Class II	2004-06-18
K040874	Red, White & Blue	Allesee Orthodontic Appliances, Inc.	NXC	Class II	2004-06-18
K040830	Pta, Ptv, Atrioseptostomy, Angiographic, Sizing Catheters	Numed Inc	DQO	Class II	2004-06-18
K040777	Lcp Radial Head Plating System	Synthes (USA) Products LLC	HRS	Class II	2004-06-18
K040730	Vascular Solutions D-Stat Clamp Hemostatic Clamp	Vascular Solutions LLC	DXC	Class II	2004-06-18
K040728	Angiodynamics, Inc., Percutaneous Introducer and Elvs Procedure Kit	Boston Scientific Corporation	DYB	Class II	2004-06-18
K040704	Modification to Henschke Hdr Cervix Applicator and Hilaris/nori Hdr Cervix Applicator	Mick Radio-Nuclear Instruments, Inc.	JAQ	Class II	2004-06-18
K040579	Choletech Ldx High-Sensitivity C-Reactive Protein (Hs-Crp)	Cholestech Corp.	DCK	Class II	2004-06-18
K033785	Proactive Care Prophylaxis Paste with Fluoride	Discus Dental LLC	EJR	Class I	2004-06-18
K032836	M3 Microkeratome	Moria SA	HNO	Class I	2004-06-18
K041542	CT-C3000dual and CT-C2800dual Family of Dual-Slice CT Scanner Systems	Neusoft Digital Medical Systems Co., Ltd.	JAK	Class II	2004-06-17
K041487	Qd Head Speeder with Speeder Nv Attachment	GE Healthcare Coils	MOS	Class II	2004-06-17
K041476	Ge Signa Excite 1.5T Mr System, Ge Signa Excite 3.0T Mr System	GE Healthcare	LNH	Class II	2004-06-17
K041339	Aequalis Shoulder System	TORNIER Inc.	KWS	Class II	2004-06-17
K041322	Vitros Immunodiagnostic Products Cea Reagent Pack/calibrator/range Verifiers	Ortho-Clinical Diagnostics, Inc.	DHX	Class II	2004-06-17
K041229	Multiple (Addition Silicone Impression Material)	Cosmedent, Inc.	ELW	Class II	2004-06-17
K041200	Thermassage Enegry Product, Model Hy-7000	Migun Medical Instrument Co., Ltd.	JFB	Class II	2004-06-17
K041165	Fsh Menopause Predictor Test	Acon Laboratories, Inc.	CGJ	Class I	2004-06-17
K041094	Hsg Catheter Set	Bioteque America Inc	LKF	Class II	2004-06-17
K041022	Neuroq - Pet Dp	Syntermed, Inc.	KPS	Class II	2004-06-17
K040864	Craniofix and Craniofix2 Titanium Clamp System	Aesculap Inc	GXN	Class II	2004-06-17
K040860	Integra Bone Fixation System	Integra LifeSciences Corporation	HRS	Class II	2004-06-17
K040847	Modification to Vamos Anesthetic Gas Monitor	Draeger, Inc.	CCK	Class II	2004-06-17
K040837	Multiject Injector and Microglide Cartridge	Medicel AG	MSS	Class I	2004-06-17