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 1288 of 3531

510(k) clearances, page 1288 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K053447	Arthrocare Perc-D Spinewand	ArthroCare Corporation	GEI	Class II	2005-12-27
K053414	Mentor Novasilk Mesh	Mentor	OTP	Class III	2005-12-27
K053276	Ist Pedicle Screw System	Innovative Spinal Technologies, Inc.	NKB	Class II	2005-12-27
K053008	E-Z-Em Endoscopic CO2 Regulator	E-Z-EM, Inc	FCX	Class II	2005-12-27
K052942	21.3Inch Monochrome Lcd Monitor	Nec-Mitsubishi Electric Visual Systems Corp.	LLZ	Class II	2005-12-27
K052917	Stryker Compartmental Knee System	Howmedica Osteonics Corp	NPJ	Class II	2005-12-27
K052875	Prostim Reusable Neurostimulation Electrodes	Summit Manufacturing, LLC	GXY	Class II	2005-12-27
K052848	Spectra Hair Removal Laser	Spectragenics, Inc.	GEX	Class II	2005-12-27
K052787	Acumatch 12/14 C-Series Cemented Femoral Stems (Size 1-6), Acumatch 12/14 L-Series Cemented Femoral Stems (Size 1-5)	Exactech, Inc.	LZO	Class II	2005-12-27
K052706	A-200 Powered Wheelchair	Otto Bock Healthcare LP	ITI	Class II	2005-12-27
K052678	Aq-830 Slim Body, Body Fat Monitor	Limax Electronics Co., Ltd.	MNW	Class II	2005-12-27
K052587	3D Accu-I-Tomo Xyz Slice View Tomograph, Model Mct-1 Exf	J. Morita USA, Inc.	JAK	Class II	2005-12-27
K052385	Tangors Polyaxial System	Ulrich GmbH & Co. KG	NKB	Class II	2005-12-27
K052265	Smith & Nephew Competitor Duo Knee Femoral	Smith & Nephew, Inc.	NPJ	Class II	2005-12-27
K051903	Fetalgard Lite-Nibp, Model Fgl-Nibp	Analogic Corp.	DXN	Class II	2005-12-27
K051290	Tampax Pearl Plastic Applicator Tampons, Ultra Absorbency (Unscented and Scented)	Procter & Gamble Co.	HEB	Class II	2005-12-27
K050365	Biophen Protein C5, C2.5, Models 221205, 221202	Hyphen Biomed Sasu	GGP	Class II	2005-12-27
K053395	Bp Pro Blood Pressure Monitor	Card Guard Scientific Survival, Ltd.	DXN	Class II	2005-12-23
K053140	Ambu Mark IV Resuscitator	Ambu A/S	BTM	Class II	2005-12-23
K053109	Dimension Cardiophase High Sensitivity Crp Flex Reagent Cartridge	Siemens Healthcare Diagnostics Inc.	NQD	Class II	2005-12-23
K053104	Dimension Cardiophase High Sensitivity C-Reactive Protein Calibrator	Siemens Healthcare Diagnostics Inc.	JIS	Class II	2005-12-23
K052885	Zygoma 17 Abutment Multi-Unit Rp 2Mm, Model 29314; Zygoma 17 Abutment Multi-Unit Rp 3Mm, Model 29315	Nobel Biocare USA LLC	NHA	Class II	2005-12-23
K052867	Vitros Chemistry Products Dtibc Reagent	Ortho-Clinical Diagnostics, Inc.	JMO	Class I	2005-12-23
K052826	Qms Quinidine. Qms Quinidine Calibrators	Seradyn, Inc.	LBZ	Class II	2005-12-23
K052819	Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance Verifiers I, II and III	Ortho-Clinical Diagnostics, Inc.	DEM	Class II	2005-12-23
K052790	Smartsite Vented Vial Access Device, Model Tbd	Cardinal Health, Alaris Products	LHI	Class II	2005-12-23
K052751	Ventlink System	Mediserve Information Systems, Inc.	MOD	Class II	2005-12-23
K052669	Avant Digital Pulse Oximetry System, Model 4000, 4100	Nonin Medical, Inc	DQA	Class II	2005-12-23
K052562	Eclipse (Cabinet Name), Teoae25, Ep15, or the Combination of Systems.	Interacoustics a/S	EWO	Class II	2005-12-23
K052471	Hdc Spider Screw	Hdc S.r.l.	DZE	Class II	2005-12-23
K052283	Heart Stg System and Software	Stethographics, Inc.	DQD	Class II	2005-12-23
K051472	Biophen Lmwh Control, Lmwh Control Low, Ufh Control, Heparin Calibrator & Ufh Calibrator	Hyphen Biomed Sasu	GGN	Class II	2005-12-23
K051041	Insulin Pump	Abbott Medical	LZG	Class II	2005-12-23
K051030	Coag-a-Mate Mtx III	bioMerieux, Inc.	JPA	Class II	2005-12-23
K050944	K-Assay Ferritin (2) & Ferritin Calibrator Set	Kamiya Biomedical Company, LLC	DBF	Class II	2005-12-23
K053458	Web1000	Agfa Corp.	LLZ	Class II	2005-12-22
K053408	Nexa Bone Plate and Screw System	Nexa Orthopedics, Inc.	HRS	Class II	2005-12-22
K053369	Medilog Darwin Holter Analysis	Huntleigh Healthcare Ltd.	DQK	Class II	2005-12-22
K053286	Modification to: Nxstage Pureflow-B Solution	NxStage Medical Inc	KPO	Class II	2005-12-22
K053279	Urovantage	Pck Electronic Industry & Trade Co., Ltd.	OWB	Class II	2005-12-22
K053241	Bd Phoenix Automated Microbiology System - Cefoxitin Gp 1-32 G/ml	Becton Dickinson & Co	LON	Class II	2005-12-22
K053055	Orthodontic Polymer Composite Bracket	Gestenco International AB	DYW	Class II	2005-12-22
K053051	Vanguard Reprocessed External Fixation Devices	Stryker Sustainability Solutions	KTT	Class II	2005-12-22
K052865	Hospira Cath Lab Convenience Kits	Abbott Medical	DQO	Class II	2005-12-22
K052864	Tyrx Surgical Mesh, Model Smpc-0501	Tyrx Pharma, Inc.	FTL	Class II	2005-12-22
K052846	Tewa Cj-Type, Pj-Type, Cb-Type and Pb-Type Acupuncture Needles for Single Use	Maanshan Medical Instruments Co., Ltd.	MQX	Class II	2005-12-22
K052743	Dynarex CPR Shield with One Way Valve and Barrier Filter, Model 4921	Dynarex Corp.	CBP	Class II	2005-12-22
K052733	Almitech Inc. Dental Implant System	Almitech, Inc.	DZE	Class II	2005-12-22
K052715	Calm Curve, Version 01.00	Lms Medical Systems (Canada), Ltd.	HGM	Class II	2005-12-22
K052553	Nitom Locking Facebow	Russell Samuels Orthodontic Design	DZB	Class II	2005-12-22