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 1387 of 3531

510(k) clearances, page 1387 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K040755	Exactech Resorbable Room Temperature Bone Paste	Exactech, Inc.	MQV	Class II	2004-06-17
K040749	Modular Replacement System Cemented Stems	Howmedica Osteonics Corp	KRO	Class II	2004-06-17
K040747	Aladyn Rigid Spine Plate	Scient'X	MNH	Class II	2004-06-17
K040721	Assure Anterior Cervical Plate System	Globus Medical, Inc.	KWQ	Class II	2004-06-17
K040612	Sky Bone Expander System (Sky System)	Disc-O-Tech Medical Technologies, Ltd.	HRX	Class II	2004-06-17
K040310	Nova Family of Medical Radiology Displays	National Display Systems	LLZ	Class II	2004-06-17
K030195	Bbp Bone Substitutes	Oct, USA, Inc.	LYC	Class II	2004-06-17
K023956	Thermometer Models St313c/f, St314c/f, St323c/f, St324c/f, St333c/f, St334c/f	Mesure Technology Co., Ltd.	FLL	Class II	2004-06-17
K041448	Hexapod Rt Couchtop	3C-Medical Intelligence GmbH	JAI	Class II	2004-06-16
K041402	Modification to Osseotite Nt Certain Implants	ZimVie US Corp LLC	DZE	Class II	2004-06-16
K041343	Xeno Nm Light Cured Dental Adhesive	Dentsply International, Inc.	KLE	Class II	2004-06-16
K041335	Ptm System	Dentsply International, Inc.	EIH	Class II	2004-06-16
K041158	Atrion Epidural Anesthesia Kit with Atrion Needlevise Sharps Securing System	Atrion Medical Products, Inc.	CAZ	Class II	2004-06-16
K041141	Dentsply Cavitron Jet Wave Air Polishing Prophylaxis System, Model G125	Dentsply Intl.	EFB	Class I	2004-06-16
K041040	Varelisa Mpo Anca, Model 17648/17696	Sweden Diagnostics (Germany) GmbH	MOB	Class II	2004-06-16
K040967	Disposable Powder Free Vinyl Examination Gloves	Zi BO Hong Wang Plastic & Rubber Products Co., Ltd.	LYZ	Class I	2004-06-16
K040906	Calibra Cement	Dentsply Intl.	EMA	Class II	2004-06-16
K040443	Dome Cx Digital Flat-Panel Display System, Model C5i	Dome Imaging Systems, Inc.	LLZ	Class II	2004-06-16
K040379	Randox Immunoassay Control	Randox Laboratories, Limited	JJY	Class I	2004-06-16
K040332	Polymedco Spotchem Ez Chemistry Analyzer	Arkray, Inc.	JJF	Class I	2004-06-16
K040030	Biocheck Cardiac-1 Crp Rapid Test, Model Bc-804114	BioCheck Inc	DCN	Class II	2004-06-16
K033896	Defibtech AED with Attenuated Defibrillation/monitoring Pads, Models Ddu-100 with Ddp-200P	Defibtech LLC	MKJ	Class III	2004-06-16
K041331	Biopsy Sciences, Llc, Lung Biopsy Site Marker	Biopsy Sciences, LLC	GDW	Class II	2004-06-15
K041220	Ge Discovery St System	GE Healthcare	KPS	Class II	2004-06-15
K041050	Digora Optime (or Digora Ontime)	Soredex Palodex Group Oy	MUH	Class II	2004-06-15
K041023	Stay-Put Impregnated	Coltene/Whaledent GmbH & Co. KG	MVL	Unclassified	2004-06-15
K040943	Medtronic Ps Medical Strata Valve	Medtronic Neurosurgery	JXG	Class II	2004-06-15
K040900	S-42 UV, T-42 UV Toric and M-42 UV Multifocal (Hefilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear	Optical Connection, Inc.	LPL	Class II	2004-06-15
K040835	Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16	Pm Devices, Inc.	FTM	Class II	2004-06-15
K040701	Synthes (USA) Hydroxyapatite (Ha) Coated Schanz Screws	Synthes (USA) Products LLC	HWC	Class II	2004-06-15
K040617	Reliant Laser System II	Reliant Technologies, Inc.	GEX	Class II	2004-06-15
K033960	Olinda/exm	Vanderbilt University	IYX	Class I	2004-06-15
K032327	Modern Medical Bipolar Forceps	Modern Medical Equipment Mfg., Ltd.	GEI	Class II	2004-06-15
K030831	Lapascopic Instruments and Electrode Tips	Modern Medical Equipment Mfg., Ltd.	GEI	Class II	2004-06-15
K041383	Stellartech Coagulation System, Models 1100C-115 and 1100C-230	Stellartech Research Corp.	GEI	Class II	2004-06-14
K041310	Stryker Wedge Suture Anchor System	Stryker Corp.	MBI	Class II	2004-06-14
K041307	Modification to Stryker Xcel Anchor System	Stryker Corp.	MAI	Class II	2004-06-14
K041305	Stryker Biozip Suture Anchor System	Stryker Corp.	MAI	Class II	2004-06-14
K040956	Hilux Ledmax 3	First Medical Infection Control Associates, Inc.	EBZ	Class II	2004-06-14
K040680	Contour Ha Coated Reconstruction Ring	Smith & Nephew, Inc.	MEH	Class II	2004-06-14
K040425	Acs:180 and Advia Centaur B-Type Natriuretic Peptide (Bnp) Assays	Medrad, Inc.	NBC	Class II	2004-06-14
K040257	Quest Diagnostics Haircheck-Dt (Thc)	Quest Diagnostics, Inc.	LDJ	Class II	2004-06-14
K041499	Ssa-770A, Aplio Version 5.5	Toshibamedical Systems Corporation	IYN	Class II	2004-06-10
K041455	Ssi-600/Ssi-800 Diagnostic Ultrasound Imaging System	Sonoscape Company Limited	IYO	Class II	2004-06-10
K041418	Airlife Misty Finity Large Volume Continuous Nebulizer	Cardinalhealth	CAF	Class II	2004-06-10
K041315	Cyberknife System for Stereotactic Radiosurgery/radiotherapy	Accuray Incorporated	IYE	Class II	2004-06-10
K041306	Numed Pts X Sizing Balloon Catheter	Numed Inc	MJN	Class II	2004-06-10
K041296	Modification to Hakim Precision Valve System, Hakim Programmable Valve System, Hakim Micro Programmable Valve System, Si	Cerenovus, Inc.	JXG	Class II	2004-06-10
K041288	Modification to Smartpin	Linvatec Biomaterials, Ltd.	HTY	Class II	2004-06-10
K041282	Modification to Tsrh Spinal System	Medtronic Sofamor Danek	KWP	Class II	2004-06-10