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 1233 of 3531

510(k) clearances, page 1233 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K062886	Ascent Pit and Fissure Sealant, Model 006-00019	Cao Group, Inc.	EBC	Class II	2006-11-06
K062807	Tsrh Spinal System	Medtronic Sofamor Danek	NKB	Class II	2006-11-06
K062412	Cryomatic	Keeler Instruments, Inc.	HRN	Class II	2006-11-06
K061908	Nicoletone System V32 Amplifier	Viasys Neuro Care	GWQ	Class II	2006-11-06
K053225	Cellu M6 Keymodule I	Lpg One, Inc.	ISA	Class I	2006-11-06
K063189	Tsx-301A, Aquilion One CT System	Toshiba America Medical Systems, In.C	JAK	Class II	2006-11-03
K063184	Model Cvv-001A Vessel View Software Option	Toshiba America Medical Systems, In.C	JAK	Class II	2006-11-03
K063173	Modification to Silver Alginate II Wound Dressing	Advanced Medical Solutions Limited	FRO	Unclassified	2006-11-03
K063117	Modification to Durepair Dura Regeneration Matrix	Medtronic Neurosurgery	GXQ	Class II	2006-11-03
K063067	Confidence Fenestrated Introducer Needle	Disc-O-Tech Medical Technologies, Ltd.	NDN	Class II	2006-11-03
K062999	Opticath Central Venous Oximetry Probe with Seal with Heparin	Abbott Medical	DQE	Class II	2006-11-03
K062715	Synthetic Vinyl Patient Exam Gloves Powder-Free, Yellow	Baoding Guanzhong Glove Co., Ltd.	LYZ	Class I	2006-11-03
K062671	14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome Sapphire)	Kendall	MSD	Class II	2006-11-03
K062597	Tenderflow Pediatric Venous Return Cannula	Terumo Cardiovascular Systems Corporation	DWF	Class II	2006-11-03
K062482	Vented Vial Adapter Transfer Device	West Pharma. Services IL, Ltd.	LHI	Class II	2006-11-03
K062469	Voyager 12	GE Healthcare	DPS	Class II	2006-11-03
K062455	Philips Adult Reusable Sp02 Sensor, Model M1191b, M1191bl, M1191bnl	Philips North America LLC	DQA	Class II	2006-11-03
K062454	Magnetom Systems - I-Class and T-Class Releases	Siemens Medi Cal Solutions, Inc.	LNH	Class II	2006-11-03
K061993	Equivital, Model Eq-01	Hidalgo Limited	MHX	Class II	2006-11-03
K061944	Poly-Chem Creatinine	Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, LLC	JFY	Class II	2006-11-03
K061233	Senstouch Powder Free Examination Gloves, Non Sterile	Pt Mahakarya Inti Buana	LYY	Class I	2006-11-03
K060421	Sonara; Sonara/tek	Viasys Healthcare GmbH	IYN	Class II	2006-11-03
K063162	Golden Liteway	Golden Technologies, Inc	INI	Class II	2006-11-02
K063130	Aplio Xg Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0	Toshibamedical Systems Corporation	IYN	Class II	2006-11-02
K063075	Natural Orifice Linear Cutter Digital Loading Units	Power Medical Interventions, Inc.	GDW	Class II	2006-11-02
K063039	Xplorer 2200 Digital Radiographic System	Imaging Dynamics Company, Ltd.	MQB	Class II	2006-11-02
K063031	Prism View, Model	Kyron Clinical Imaging, Inc.	LLZ	Class II	2006-11-02
K063029	Empower Ct/cta Injector System, Model 9800/9900	E-Z-EM, Inc	JAK	Class II	2006-11-02
K063006	Ge Logiq Works	General Electric Co.	LLZ	Class II	2006-11-02
K062917	Sterile and Non-Sterile Powder-Free Latex Patient Examination Glove, with Extractable Protein Content Labeling Claim (50	Wear Safe (Malaysia) Sdn Bhd	LYY	Class I	2006-11-02
K062914	Hem-O-Lok Ligation Clip	Teleflex Medical	FZP	Class II	2006-11-02
K062754	Gas Module Se, Model 0998-00-0481-02	Datascope Corp.	BZK	Class II	2006-11-02
K062740	Jindell High Spped Air Turbine Handpiece, Models Sw, Sp, Su, Etu, Mu	Jindell Medical Instruments Co., Ltd.	EFB	Class I	2006-11-02
K062713	Adhesive Dc Activator	Ivoclar Vivadent, Inc.	KLE	Class II	2006-11-02
K062642	RF Surgical Systems Inc. Detection System, Model 100A	Rf Surgical Systems, Inc.	LWH	Class I	2006-11-02
K062343	Grandio Flow Try-in	Voco GmbH	EBF	Class II	2006-11-02
K062341	Male Remeex System	Specialities Remeex International, S.L.	OTM	Class II	2006-11-02
K062174	Modification to Expedium Spine System	DePuy Spine, Inc.	MNH	Class II	2006-11-02
K062081	Lithogold	Tissue Regeneration Technologies	LNS	Class II	2006-11-02
K062030	US System	OSSTEM Implant Co., Ltd.	DZE	Class II	2006-11-02
K061796	Hepatostat Set, Model 760X	Vygon Corp.	GAM	Class II	2006-11-02
K061316	Medline Surgical Sponge Scanner	MEDLINE INDUSTRIES, LP - Northfield	LWH	Class I	2006-11-02
K061288	Auto Suture Endo Clip III 5 Mm Clip Applier	United States Surgical, A Division of Tyco Healthc	FZP	Class II	2006-11-02
K060987	Oscera7 Synthetic Absorbable Bone Wax, Model Os31	Cp Medical	MTJ	Unclassified	2006-11-02
K063101	Microscan Microstrep Plus Panel Cefotaxime (0.015 - 8 Mcg/ml	Siemens Healthcare Diagnostics Inc.	LRG	Class II	2006-11-01
K063099	Microscan Microstrep Plus Panel Cefepime (O.015 - 8 Mcg/ml)	Siemens Healthcare Diagnostics Inc.	LRG	Class II	2006-11-01
K063033	Modification to Titanium Shoulder Plate Implant	Orthopedic Sciences, Inc	HRS	Class II	2006-11-01
K062876	Primaconnex Ceramic Abutments	Lifecore Biomedical LLC	NHA	Class II	2006-11-01
K062816	Sensititre Haemophilus/streptococcus Pneumoniae (Hp) Mic Plate	Trek Diagnostic Systems, Ltd.	JWY	Class II	2006-11-01
K062614	Vistakon (Etafilcon a) Soft (Hydrophilic) Contact Lens, Clear and Tinted (Visibility And/or Cosmetically)	Johnson & Johnson Vision Care, Inc.	LPL	Class II	2006-11-01