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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 839 of 3530

510(k) clearances, page 839 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K113539	Revois Pro Implant Stsyem	Riemser Arzneimittel AG	DZE	Class II	2013-05-03
K130870	Hitachi Clinical Analyzer S Test Reagent Cartridge Calcium (Ca)	Canon Medical Diagnostics USA, Inc.	CIC	Class II	2013-05-02
K130811	Psychemedics Microplate Eia for Amphetamine	Psychemedics Corp.	DKZ	Class II	2013-05-02
K130605	Inomax Dsir (Delivery System)	Mallinckrodt Manufacturing LLC	MRN	Class II	2013-05-02
K130591	Supera Veritas	Idev Technologies, Inc.	FGE	Class II	2013-05-02
K130346	Synergy Focus Desktop Version; Synergy Focus Laptop Version	Medtronic, Inc.	GWF	Class II	2013-05-02
K130330	Range Spinal System	K2M, Inc	OSH	Class II	2013-05-02
K130174	Dvtcare Ca5	Ossur Americas	JOW	Class II	2013-05-02
K130039	Revaclear 300 Dialyzer, Revaclear 400 Dialyzer	Gambro Renal Products	KDI	Class II	2013-05-02
K123971	Cynosure 1064Nm Diode Laser	Cynosure, LLC	ILY	Class II	2013-05-02
K123953	Ace Carbon Dioxide Reagent, Ace Direct Biliubin Reagent, Ace Total Bilirubin Reagent, Ace Magnesium Reagent	Alfa Wassermann Diagnostic Technologies, Inc.	KHS	Class II	2013-05-02
K123500	Aquilion Lb Triton V4.91	Toshibamedical Systems Corporation	JAK	Class II	2013-05-02
K122525	Smartest Glucowise Blood Glucose Monitoring System, and Smartest Glucoswise Multi Blood Glucose Monitoring System	Biotest Medical Corp.	NBW	Class II	2013-05-02
K122388	Seca Medical Body Compostion Analyzer 514, Seca Mbca 514, Seca Mbca, Seca 514	Seca GmbH & Co. KG	MNW	Class II	2013-05-02
K122368	Waterlase Iplus All Tissue Laser	Biolase MG LLC	GEX	Class II	2013-05-02
K122196	Cervello Bio-Potential Signal Acquistion System Product Family	Blackrock Neuromed	GWQ	Class II	2013-05-02
K120532	Getinge 633Hc Steam Sterilizer Air Glide System	Getinge Sourcing, LLC	PEC	Class II	2013-05-02
K130968	Ventralight St Mesh with Echo Ps Positioning System	C.R. Bard Inc	FTL	Class II	2013-05-01
K130899	Biolox Delta Ceramic Femoral Heads	Zimmer GmbH	LZO	Class II	2013-05-01
K130626	Mac-Lab Hemodynamic Recording System; Cardiolab Electrophysiology Recording System; Combolab Hemodynamic and Electrophys	GE Medical Systems Information Technologies, Inc.	DQK	Class II	2013-05-01
K130434	Octane Straight, Octane Straight - Lordotic, Octane Straight I/r, Octane Straight I/r - Lordotic	Exactech, Inc.	MAX	Class II	2013-05-01
K130216	Atlantis Straumann Bone Level Abutment	Dentsply Implant	NHA	Class II	2013-05-01
K130169	Fms Vue Fluid Managment System, Fms Connect Interface Cable	DePuy Mitek, Inc.	HRX	Class II	2013-05-01
K123932	Zygafix Spinal Facet Screw System	Xtant Medical Holdings, Inc.	MRW	Unclassified	2013-05-01
K123636	H200 Wireless Hand Rehabilitation System with Optional Intelli-Connect Earpiece Triggering Device	Bioness, Inc.	GZI	Class II	2013-05-01
K123550	Utf Stem, Reduced	United Orthopedic Corp.	LPH	Class II	2013-05-01
K122595	Hydropermeate Topical Emulsion, Answer2skin Sunburn Relief Cream, Answer2skin First Aid Cream	Dermal Life, LLC	FRO	Unclassified	2013-05-01
K122347	Elisio-H and Elisio-M Hemodialyzers	Nipro Medical Corporation	KDI	Class II	2013-05-01
K121613	Agilia Infusion System	Fresenius Kabi AB	FRN	Class II	2013-05-01
K121401	Tender Touch	Sometech Corporation	ILY	Class II	2013-05-01
K130957	Wvsm (Wirless Vital Signs Monitor)	Athena GTX	MWI	Class II	2013-04-30
K130518	Mini-Midline Extended Dwell Safety Catheter	Luther Needlesafe Products LLC	FOZ	Class II	2013-04-30
K130233	Neurostar Tms Therapy System	Neuronetics Inc.	OBP	Class II	2013-04-30
K123941	Kobold Sure-Guide Vaginal Cylinder Set, Stump Vaginal Cylinder Set, Miami Cylinder Set	Spencer Fillmore	JAQ	Class II	2013-04-30
K122945	Steritec Green Card Pack Bowie-Dick Test Model Bd 126	Steritec Products Mfg. Co., Inc.	JOJ	Class II	2013-04-30
K122905	Peregrine 23Ga Curved Laser Probe	Peregrine Surgical, LLC.	HQB	Class II	2013-04-30
K122888	Cdr Systems Precision Patient Positioning System	CDR Systems, Inc.	IYE	Class II	2013-04-30
K122767	Nmi Port	Boston Scientific Corporation	LJT	Class II	2013-04-30
K122664	Zuga Dental Implant System	Zuga Medical, Inc.	DZE	Class II	2013-04-30
K120599	Depuy M-Spec 36Mm Femoral Heads	Depuy Orthopaedics Inc.	LPH	Class II	2013-04-30
K130762	Audit Microcv Therapeutic Drug (Tdm) Linearity Set	Aalto Scientific Ltd.	JJY	Class I	2013-04-29
K130482	Combat Ready Clamp	Safeguard US Operating LLC	DXC	Class II	2013-04-29
K130406	Diagnosticpro Edge	Vidar Systems Corp.	LMA	Class II	2013-04-29
K130222	Straumann Dental Implant System	Straumann USA, LLC	DZE	Class II	2013-04-29
K130202	Iris Anterior Cervical Plate	Life Spine	KWQ	Class II	2013-04-29
K123601	Single Use Repositionable Clip	Olympus Medical Systems Corp.	PKL	Class II	2013-04-29
K123482	Reflow Aspiration Catheter	Volcano Corporation	QEZ	Class II	2013-04-29
K123470	Pas Alcovisor Mars, Pas Alcovisor Satellite	Pas Systems International Inc	DJZ	Class I	2013-04-29
K123421	Olympus Small Intestinal Capsule Endoscope System	Olympus Medical Systems Corp.	NEZ	Class II	2013-04-29
K130876	Cg+ Arrow Picc Powered by Arrow Vps Stylet	Arrow International LLC (subsidiary of Teleflex Incorporated)	LJS	Class II	2013-04-26