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 1468 of 3531

510(k) clearances, page 1468 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K020754	Nicolet Pioneer Tc8080	Nicolet Biomedical, Inc.	IYN	Class II	2003-04-21
K030885	Modification to Stryker Painpump2	Stryker Corp.	FRN	Class II	2003-04-18
K030880	Vectorsonic, Model Vu-270	Metron Medical Australia, Pty, Ltd.	IMG	Class II	2003-04-18
K030866	Synthes Anterior Cslp System	Synthes (USA) Products LLC	KWQ	Class II	2003-04-18
K030735	Modified Verte-Stack Spinal System	Medtronic Sofamor Danek	MQP	Class II	2003-04-18
K030430	Poly Stat Serum/urine Hcg Test	Alidex, Inc.	JHI	Class II	2003-04-18
K030427	Hp-3 Hd Electric Wheelchair	Imc-Heart Way LLC	ITI	Class II	2003-04-18
K030231	Coronary Artery Perfusion Cannula with Self-Inflating Balloon	Corcym Inc.	DWF	Class II	2003-04-18
K023365	Leforte System Bone Screw	Jeil Medical Corporation	HWC	Class II	2003-04-18
K022950	Miniphysionizer 2.0 and Electrodes	Physion, Inc.	EGJ	Class II	2003-04-18
K021421	Padtac Electrophysiology Recording Catheters, Junction Cable Connector & Cable	TZ Medical Inc.	DRF	Class II	2003-04-18
K031013	Infintt Co., Ltd. Starpacs System	Infinitt Co., Ltd.	LLZ	Class II	2003-04-17
K030934	Ge Logiq 9 Model 2375600	GE Healthcare	IYN	Class II	2003-04-17
K030927	Powdered Vinyl Exam Gloves, White	Copioumed Intl., Inc.	LYZ	Class I	2003-04-17
K030862	Blackstone Spinal Fixation System Rigid Cross Connector	Blackstone Medical, Inc.	MNI	Class II	2003-04-17
K030855	Modification to Endovive Initial Placement Peg Kit, Direct Pej Kit, Peg Safety Kit	Boston Scientific Corporation	KNT	Class II	2003-04-17
K030791	Anmp (Acoustic Neuro Modulation Protocol)	Tinnitech, Ltd.	KLW	Class II	2003-04-17
K030613	Vital Signs Monitor W/arrhythmia Detection and St Analysis, Model 8100	Criticare Systems, Inc.	MHX	Class II	2003-04-17
K030533	Accunate One-Step,accunate One-Step Cassette, Accunate-Choice, Accunate Home Pregnancy Test	Cenogenics Corp.	LCX	Class II	2003-04-17
K030516	Riva-Self Cure	Southern Dental Industries, Inc.	EMA	Class II	2003-04-17
K030499	Hl888hm	Health & Life Corporation	DXN	Class II	2003-04-17
K030471	Ophtec Enclavation Needle	Ophtec USA, Inc.	HNQ	Class I	2003-04-17
K030402	Arthroscopy Pump, Model A107	Novanta Medical GmbH	HRX	Class II	2003-04-17
K030291	Coulter Act 5Diff Autoloader (Al)	Siemens Healthcare Diagnostics Inc.	GKZ	Class II	2003-04-17
K030181	International Biophysics Corporation (Ibc) Laser Peel System	International Biophysics Corp.	GEX	Class II	2003-04-17
K030176	Lifestyles, Contempo or Private Label-Male Latex Condom with Desensitizing Lubricant	Suretex, Ltd.	HIS	Class II	2003-04-17
K030175	2 Basic	Mirion Technologies (Capintec), Inc.	IYE	Class II	2003-04-17
K023947	Gc Oia	Thermo Biostar, Inc.	LIR	Class II	2003-04-17
K023939	Velocity Advantage	Visioncare Devices, Inc.	HQE	Class II	2003-04-17
K023234	Endoscopic Plication System	Ndo Surgical, Inc.	ODE	Class II	2003-04-17
K030954	Arthrocare Percd Spinewand	ArthroCare Corporation	GEI	Class II	2003-04-16
K030854	Protoco2l Colon Insufflator with Performance Improvements, Model 6400	E-Z-EM, Inc	FCX	Class II	2003-04-16
K030540	Hts Array Coil	Jockey Club Mri Engineering Center	MOS	Class II	2003-04-16
K030208	Imbibe II Syringe	DSM Biomedical, Inc.	FMF	Class II	2003-04-16
K030165	Thermatrek Iris-IV Infrared Imaging System	Thermatrek	LHQ	Class I	2003-04-16
K024285	A/t X-Ray 70	Air Techniques, Inc.	EHD	Class II	2003-04-16
K021672	Pancreatic Drainage Tube	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	FGE	Class II	2003-04-16
K030436	Bio Universal	Ivoclar Vivadent, Inc.	EJT	Class II	2003-04-15
K030435	Biouniversal Pkf	Ivoclar Vivadent, Inc.	EJT	Class II	2003-04-15
K030385	IV Add-on Filter Administration Set with and without Y Connect or Needleless Access Connector	Kawasumi Laboratories America, Inc.	FPA	Class II	2003-04-15
K030292	Groman Prepmaster	Groman Inc.	KOJ	Class II	2003-04-15
K030147	Lumenis Family of Ultrapulse Surgitouch CO2 Surgical Lasers	Lumenis Ltd	GEX	Class II	2003-04-15
K023547	Diolase 980 D Laser System	American Dental Technologies, Inc.	GEX	Class II	2003-04-15
K031022	Protec-Top, Sterident, Bento	Ronpak, Inc.	FRG	Class II	2003-04-14
K030650	Stoneguard II Reagent Strips for Urinalysis and Confirm Control Solutions	Uridynamics, Inc.	CEN	Class I	2003-04-14
K030620	Pasco Mic and Mic/id Panels	Pasco Laboratories, Inc.	LTT	Class II	2003-04-14
K030603	Proangle Disposable Prophy Angle	Pac-Dent International (Suzhou), Ltd.	EGS	Class I	2003-04-14
K030447	At Home Drug Cup, Model 9150X	Phamatech Inc.	MVO	Unclassified	2003-04-14
K030422	Lina-Bag, Models Lb-60, Lb-100	Lina Medical Cml ApS	GCJ	Class II	2003-04-14
K030416	Ceracast-V	Mountain Medico, Inc.	EJH	Class II	2003-04-14