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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 685 of 3530

510(k) clearances, page 685 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K141876	Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95 Respirator, Pasture A520S Surgical N95 Respirator, Pasture A520CS Surgical N95 Respirator, Pasture E520S Surgical N95 Respirator, Pasture E520CS Surgical N95 Respirator	Pasture Pharma Pte Ltd	MSH	Class II	2015-10-28
K153003	SIGNA Pioneer	GE Healthcare	LNH	Class II	2015-10-27
K152874	BD Veritor System for the Rapid Detection of Flu A + B Laboratory kit	Becton Dickinson & Co	PSZ	Class II	2015-10-27
K152870	BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kit	Becton Dickinson & Co	PSZ	Class II	2015-10-27
K152801	Ultracheck Spacelabs Abp Cuff-Child, Ultracheck Spacelabs Abp Cuff-Small Adult, Ultracheck Spacelabs Abp Cuff-Adult, Ultracheck Spacelabs Abp Cuff-Large Adult	Statcorp Medical	DXQ	Class II	2015-10-27
K152607	Express SD Biliary Monorail Premounted Stent System	Boston Scientific Corporation	FGE	Class II	2015-10-27
K152457	CD HORIZON Spinal System	Medtronic Sofamor Danek USA Inc	NKB	Class II	2015-10-27
K152363	Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra long), Value Care Cuff Adult, Value Care Cuff Small Adult, Value Care Cuff Pediatric, Value Care Cuff Infant, Efficia Adult NIBP Airhose, 3 M, Efficia Adult NIBP Air Hose, 1.5 M	Philips North America LLC	DXQ	Class II	2015-10-27
K152169	Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial Inserts	Ortho Development Corp.	JWH	Class II	2015-10-27
K152152	Codman Certas Plus Programmable Valve	Medos International SARL	JXG	Class II	2015-10-27
K151954	A7 Anesthesia System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	BSZ	Class II	2015-10-27
K151865	PremiPatch PTFE Pledget	Aesculap Inc	DXZ	Class II	2015-10-27
K151769	Anchorage 2 CP System	Stryker Corp.	HRS	Class II	2015-10-27
K151629	Guardian 1000	Quanta System Inc.	GEX	Class II	2015-10-27
K150780	Acetabular Cup Orientation System	Materialise N.V.	PLW	Class II	2015-10-27
K150241	Genesis II XLPE Resurfacing Patellar Components	Smith & Nephew, Inc.	JWH	Class II	2015-10-27
K143306	ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe	Erbe USA Inc	GEI	Class II	2015-10-27
K152665	PolarCath Peripheral Dilatation System	Nucyro Vascular, LLC	LIT	Class II	2015-10-26
K152092	Resection Electrodes	Olympus Winter & Ibe GmbH	FAS	Class II	2015-10-26
K152028	Volpara Imaging Software	Matakina Technologies Limited	LLZ	Class II	2015-10-26
K151882	Varian Treatment (VTx)	Varian Medical Systems, Inc.	IYE	Class II	2015-10-26
K151489	Retrieval bag system	Beacon Surgical, Inc.	GCJ	Class II	2015-10-26
K151182	LiquiBand Exceed	Advanced Medical Solutions (Plymouth), Ltd.	MPN	Class II	2015-10-26
K150270	ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, and ST AIA-PACK 25-OH Vitamin D Pretreatment Set	Tosoh Bioscience Inc	MRG	Class II	2015-10-26
K152800	illumigene Mycoplasma DNA Amplification Assay	Meridian Bioscience Inc	OZX	Class II	2015-10-23
K152677	geko T-2 Neuromuscular Stimulator	Firstkind Ltd	IPF	Class II	2015-10-23
K152560	Bard Snare Retrieval Kit	Neometrics, Inc.	MMX	Class II	2015-10-23
K152474	Avitus Bone Harvester	Avitus Orthopaedics, Inc	KNW	Class II	2015-10-23
K152371	Vantage Titan 3T	Toshibamedical Systems Corporation	LNH	Class II	2015-10-23
K152106	Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart	Vatech Co., Ltd.	OAS	Class II	2015-10-23
K151821	ER-REBOA Catheter	Pryor Medical Devices, Inc.	DQY	Class II	2015-10-23
K151600	R-40 EEG Amplifier	Lifelines Ltd.	GWL	Class II	2015-10-23
K151593	Cellvizio 100 Series System with Confocal Miniprobes	Mauna Kea Technologies	OWN	Class II	2015-10-23
K151336	LightStim Professional 2-Panel Light	LED Intellectual Properties LLC	OHS	Class II	2015-10-23
K150936	SureClip	ConMed Corporation	FZP	Class II	2015-10-23
K150606	Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug Calibrator/Control Level 1, Level 2 Level 3, Level 4, Emit II Plus Specialty Drug Control Negative, Emit II Plus Specialty Drug Control Positive	Siemens Healthcare Diagnostics Inc.	DJG	Class II	2015-10-23
K150323	FEMTO LDV Z8 Surgical Laser	Sie Ag,Surgical Instrument Engineering	OOE	Class II	2015-10-23
K150203	Medentika CAD/CAM Abutments	Medentika GmbH	NHA	Class II	2015-10-23
K150141	Orthodontics Bracket	Speed Dental Co., Ltd.	NJM	Class II	2015-10-23
K143670	Ics Chartr Ep 200 with Vemp	Natus Medical Denmark ApS	GWJ	Class II	2015-10-23
K143235	RF20000a Controller, FLOW 50 Wand	ArthroCare Corporation	GEI	Class II	2015-10-23
K152784	Pacel Bipolar Pacing Catheters	Abbott Medical	LDF	Class II	2015-10-22
K152180	Peak	Neosil Co., Ltd.	ELW	Class II	2015-10-22
K152096	DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive	Ethicon, Inc	MPN	Class II	2015-10-22
K151911	WorkMate Claris System, WorkMate Claris System Display Plus	Abbott Medical	DQK	Class II	2015-10-22
K151895	Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle	Boston Scientific Corporation	FCG	Class II	2015-10-22
K151893	P.R.O. CG Manual Wheelchair	Freedom Designs Inc	IOR	Class I	2015-10-22
K151578	Carbamazepine Gen 4	Roche Diagnostics Operations (Rdo)	KLT	Class II	2015-10-22
K151386	C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic	Atrium Medical Corporation	FTL	Class II	2015-10-22
K150902	330psi Extension Y-Line with Dual Check Valve	Coeur, Inc.	DXT	Class II	2015-10-22