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 1411 of 3531

510(k) clearances, page 1411 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K032958	Piezolith 3000 Lithotripter, Model 3000	United Medical Systems, Inc.	LNS	Class II	2004-02-17
K032903	Acon Coc-150 One Step Cocaine Test Strip & Acon Coc-150 One Step Cocaine Test Device	Acon Laboratories, Inc.	DIO	Class II	2004-02-17
K023651	Vectorvision Cranial/ent	Brainlab, Inc.	HAW	Class II	2004-02-17
K040243	Bard Atlas Pta Balloon Dilatation Catheter	C.R. Bard Inc	DQY	Class II	2004-02-13
K040138	Viceroy Inflation Device	Merit Medical Systems, Inc.	MAV	Class II	2004-02-13
K040097	Medline Strider Midi 3	MEDLINE INDUSTRIES, LP - Northfield	INI	Class II	2004-02-13
K040078	Cannon II Plus	Arrow International LLC (subsidiary of Teleflex Incorporated)	MSD	Class II	2004-02-13
K040062	Levia Phototherapy System	Lerner Medical Devices, Inc.	FTC	Class II	2004-02-13
K040014	Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator and Soft Introducers for Sizes 7, 8 and 9Mm Tubes Only	Abbott Medical	JOH	Class II	2004-02-13
K034036	Marathon Flow Directed Micro Catheter, Model 105-5055	Medtronic, Inc.	KRA	Class II	2004-02-13
K034007	Hemosil Factor VIII Deficient Plasma	Instrumentation Laboratory Co.	GJT	Class II	2004-02-13
K033883	Optetrak Total Knee System, Hi-Flex Asymmetric Posterior-Stabilized Cemented Femoral Components, Hi-Flex Posterior-Stabi	Exactech, Inc.	JWH	Class II	2004-02-13
K033873	Elecsys C-Peptide Calset	Roche Diagnostics GmbH	JIX	Class II	2004-02-13
K033838	Titanium Toggle Button(s)	Biomet Manufacturing Corp	MBI	Class II	2004-02-13
K033791	Bayer Specific Protein Reference Serum	Medrad, Inc.	JIX	Class II	2004-02-13
K033769	Eius Unicompartmental Knee System	Howmedica Osteonics Corp	HSX	Class II	2004-02-13
K033721	Vascular Solutions Auto-Fill Syringe Kit	Vascular Solutions LLC	FMF	Class II	2004-02-13
K033715	Picosat II Sp02 Pulse Oximetry Module and M3001a Multi-Measurement Server	Philips North America LLC	DQA	Class II	2004-02-13
K033615	Wfsi's Reprocessed Compression Sleeve Devices	Wheaton Franciscan Services Inc., Supply Chain	JOW	Class II	2004-02-13
K033270	Novosci Ready System, Model Rs-200	Novosci Corp	KFM	Class II	2004-02-13
K032813	The Ultra System Sp	Promedica, Inc.	KCT	Class II	2004-02-13
K032619	Microstat Pva Foam Embolization Particles	Surgica Corp.	HCG	Class II	2004-02-13
K031931	Echo Sounder Ex-101Ex 8 Mhz	Koven Technology, Inc.	DPW	Class II	2004-02-13
K031745	Infant Flow Plus Infant CPAP System with Sipap Function	Sensor Medics Corp.	BZD	Class II	2004-02-13
K040140	Iq Guide Wire	Boston Scientific Corporation	DQX	Class II	2004-02-12
K040118	Vascular Solutions D-Stat Dry Hemostatic Bandage, the D-Stat Radial Hemostatic Band and the D-Stat 2 Dry Hemostatic	Vascular Solutions LLC	QSX	Unclassified	2004-02-12
K040072	Modification to Cd Horizon Spinal System	Medtronic Sofamor Danek	MNH	Class II	2004-02-12
K040066	Siremobile C06	Siemens Medical Solutions USA, Inc.	OXO	Class II	2004-02-12
K033718	Maxbraid Polyester Plus and Polyethylene Plus Suture	Arthrotek, Inc.	GAT	Class II	2004-02-12
K033426	Liaison N-Tact Pth	Diasorin Inc.	CEW	Class II	2004-02-12
K033340	Leksell Surgiplan with Imagemerge	Elekta Instrument AB	HAW	Class II	2004-02-12
K033011	Zimmer Ortho Guidance Systems- Knee Instruments	Zimmer GmbH	HAW	Class II	2004-02-12
K032844	Liaison 25 Oh Vitamin D	Diasorin Inc.	MRG	Class II	2004-02-12
K032815	Precision Surgery Limited Variable and Fixed Cervical Plate System	Precision Surgery, Ltd.	KWQ	Class II	2004-02-12
K032446	Medline Strider, Models Midi 3 and Midi 4	MEDLINE INDUSTRIES, LP - Northfield	INI	Class II	2004-02-12
K032371	Titanium Mesh System	Encore Medical, LP	MQP	Class II	2004-02-12
K040034	Blackstone Ascent Poct System Lateral Offset Adapter	Blackstone Medical, Inc.	MNI	Class II	2004-02-11
K033573	Linvatec 10K Irrigation System	Linvatec Corporation	HRX	Class II	2004-02-11
K032677	Sysmex Poch-100I	Sysmex America, Inc.	GKL	Class II	2004-02-11
K032338	Trio Monitor Model 0998-00-0600	Datascope Corp.	MWI	Class II	2004-02-11
K032305	Omron Intellisense Digital Blood Pressure Monitor, Model Hem-907Xl	Omron Healthcare Co., Ltd.	DXN	Class II	2004-02-11
K023889	Wiener Lab. Chagatest Elisa Recomninante V.3.0, Model 96 Tests Cat. Nr. 1203254	Wiener Laboratories Saic	MIU	Class I	2004-02-11
K033941	Millennium Microsurgical System and Peristaltic Phaco Pack	Bausch & Lomb Incorporated	HQF	Class II	2004-02-10
K033840	Cellavision Dm96 Automatic Hematology Analyzer	Cellavision AB	JOY	Class II	2004-02-10
K033800	Capiox Cardiotomy Reservoir	Terumo Cardiovascular Systems Corporation	DTN	Class II	2004-02-10
K033622	Polarcath Peripheral Dilatation System	Cryo Vascular Systems, Inc.	DQY	Class II	2004-02-10
K033601	Labone Micro-Plate Cotinine Eia	Labone, Inc.	DLJ	Class II	2004-02-10
K032706	Microscan Dried Gram-Negative Mic/combo Panels with Ertapenem (0.002-32 Mcg/ml	Siemens Healthcare Diagnostics Inc.	JWY	Class II	2004-02-10
K032463	Curad Silver Bandage	Beiersdorf, Inc.	FRO	Unclassified	2004-02-10
K032462	Curad Silver Active Gel Bandage	Beiersdorf, Inc.	FRO	Unclassified	2004-02-10