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 2026-11-02, 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 977 of 3531

510(k) clearances, page 977 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K110330	Fully Automatic Electronic Blood Pressure Monitor	Andon Health Co., Ltd	DXN	Class II	2011-02-18
K110167	Presep Oligon Oximetry Catheters (16 Cm, W/heparin), (20Cm, W/heparin)	Edwards Lifesciences LLC	DQE	Class II	2011-02-18
K103701	Advia Chemistry Liquid Specific Protein Calibrators	Siemens Healthcare Diagnostics Inc.	JIX	Class II	2011-02-18
K103576	Mim 5.2 (Brachy)	MIM Software Inc	LLZ	Class II	2011-02-18
K103558	Synthes Scout Vessel Guard	Synthes GmbH	OMR	Class II	2011-02-18
K103302	Stempro Msc Sfm	Life Technologies Corporation	NDS	Class II	2011-02-18
K103260	Vascular Positioning System (Vps System) Console	Teleflex Medical	OBJ	Class II	2011-02-18
K103255	Vascular Positioning System Tm (Vps Tm System) Stylet	Teleflex Medical	OBJ	Class II	2011-02-18
K103226	Sterilization Mats	STERIS Corporation	KCT	Class II	2011-02-18
K102968	Infinity Cnap Smartpod	Draeger Medical Systems, Inc.	DXN	Class II	2011-02-18
K102961	Holter in-Line Shunt Filter, Holter Cerebral Catheter Reservoir, Accu-Flo Connectors; Accu-Flo Three Way Connector; Codm	Cerenovus, Inc.	JXG	Class II	2011-02-18
K102840	Patient Examination Gloes	Thai Hua Holding Co., Ltd.	LYY	Class I	2011-02-18
K102776	Extra-Oral, Additive Computer Aided Manufacture and Curing System	Deltamed GmbH	EBG	Class II	2011-02-18
K102560	Reprocessed Pulse Oximeter Sensors	Sterilmed Inc	NLF	Class II	2011-02-18
K102295	X2abs Dual Channel Fitness Belt	Leto Enterprises Incorporation	NGX	Class II	2011-02-18
K102259	Dental Computed Tomography X-Ray System	Vatech Co., Ltd.	JAK	Class II	2011-02-18
K102206	Eli 10 Electrocardiograph Model Eli 10	Mortara Instrument, Inc.	DPS	Class II	2011-02-18
K102076	Liquiband Dual, Model Lbd 001	Medlogic Global Limited	MPN	Class II	2011-02-18
K101838	Vts1000	Vuetek Scientific, LLC	KZA	Class I	2011-02-18
K101388	Fastpack Testo Immunoassay	Qualigen Inc	CDZ	Class I	2011-02-18
K101233	Safe'n'sound Passive Delivery System	Rexam Pharma	MEG	Class II	2011-02-18
K110238	G-Scan	Esaote S.p.A.	LNH	Class II	2011-02-17
K110207	Aloka Prousound F75 Diagnostic Ultrasound System	Aloka Co., Ltd.	IYN	Class II	2011-02-17
K110168	Zoll E Series with 2010 Aha Guidlines Software Update	ZOLL Medical Corporation	MKJ	Class III	2011-02-17
K110160	Bel-Cypher N	Takara Belmont Corporation	MUH	Class II	2011-02-17
K110154	Zoll AED Plus with 2010 Aha Guidlines Software Update	ZOLL Medical Corporation	MKJ	Class III	2011-02-17
K110118	Stimtrode Single Use Nerve Stimulator	Xavant Technology (Pty) Ltd	BXN	Class II	2011-02-17
K110008	Golife Nasal Mask	Respironics, Inc.	BZD	Class II	2011-02-17
K103490	Expedium Spine System, Moss Miami Spine System	Johnson & Johnson	NKB	Class II	2011-02-17
K103391	Ivobase Hybrid, Ivobase High Impact	Ivoclar Vivadent, Inc.	EBI	Class II	2011-02-17
K103383	Spartek Variable Angle Pedicle Screw Posterior Fusion System	Spartek Medical, Inc.	NKB	Class II	2011-02-17
K103175	Filmarray Respiratory Panel (Rp)	Idaho Technology, Inc.	OCC	Class II	2011-02-17
K103001	Rockwood Clavicle Pins	Depuy Orthopaedics Inc.	JDW	Class II	2011-02-17
K102803	Clarity Advanced Ceramic Brackets	3M UNITEK Corporation	NJM	Class II	2011-02-17
K101893	Nexus Biowave 7W Lite Ir Lamp System, Nexus Biowave 10W Lite Ir Lamp System, Nexus Biowave 30W Pro Ir Lamp System, Nexus	USA Laser Biotech, Inc.	ILY	Class II	2011-02-17
K101510	Fractional Skin Resurfacing (Fsr) Applicator	Endymed Medical Inc.	OUH	Class II	2011-02-17
K100024	Teco Diagnostics Uti Detection Strips	Teco Diagnostics	JMT	Class I	2011-02-17
K093610	Modified Retriever (Modified, Line Extension), Models 90152, 90153	Concentric Medical, Inc.	NRY	Class II	2011-02-17
K110183	Arthrocare Parallax Contour Vertebral Augmentation Device	ArthroCare Corporation	NDN	Class II	2011-02-16
K103836	Enzyme II Calibrator	Siemens Healthcare Diagnostics Inc.	JIT	Class II	2011-02-16
K103678	Case Cardiac Testing System, Cs Cardiac Testing System	GE Medical Systems Information Technologies, Inc.	DQK	Class II	2011-02-16
K103665	Conmed R Sabre Genesis Tm Electrosurgical Unit; Coned R Sabre Genesis Tm Electrosurgical Unit (230V); Conmed Hyfresurg O	ConMed Corporation	GEI	Class II	2011-02-16
K103494	Zenostar Magic Glaze	Wieland Dental + Technik GmbH & Co. KG	EIH	Class II	2011-02-16
K103355	Gdc 360 Deteachable Coil	Boston Scientific Corporation	HCG	Class II	2011-02-16
K103321	Dana Reusable Testpack for Steam Sterilization for 10 Minute Extended Cycles	Dana Products, Inc.	FRC	Class II	2011-02-16
K102637	Dynarex Ultrasound Gel	Dynarex Corp.	MUI	Class II	2011-02-16
K110287	Philips ECG Leadwire Set	Philips North America LLC	DSA	Class II	2011-02-15
K110176	Axsos Locked Plating 4.0Mm Locking Inserts	Howmedica Osteonics Corp., dba Stryker Orthopaedics	HRS	Class II	2011-02-15
K110110	Atrium Centrilfx Mesh	Atrium Medical Corporation	FTL	Class II	2011-02-15
K110056	Afinion Analyzer	Axis-Shield Poc AS	LCP	Class II	2011-02-15