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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 644 of 3529

510(k) clearances, page 644 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K161531	IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60; IntelliVue Patient Monitors MP70, MP80, MP90;IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX600;IntelliVue Patient Monitors MX700, MX800	Philips Medizin Systeme Boeblingen GmbH	MHX	Class II	2016-07-01
K161523	INDIGO Aspiration System	Penumbra Inc.	QEW	Class II	2016-07-01
K161302	Pc ECG	Edan Instruments, Inc.	DPS	Class II	2016-07-01
K160904	Expedium Spine System, VIPER and VIPER 2 Systems	Medos International SARL	NKB	Class II	2016-07-01
K160604	Cure™ Anterior Cervical Plate (ACP) System	Meditech Spine, LLC	KWQ	Class II	2016-07-01
K153674	Sorbact Foam Gentle Border, Sorbact Superabsorbent	Abigo Medical AB	FRO	Unclassified	2016-07-01
K161556	CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit	Centers for Disease Control and Prevention (CDC)	OZE	Class II	2016-06-30
K161539	Arthrosurface Bone Screws	Arthrosurface, Inc.	HWC	Class II	2016-06-30
K161526	LIAISON CMV IgM Serum Control Set	Diasorin Inc.	JJX	Class I	2016-06-30
K161522	LIAISON EBV IgM Serum Control Set	Diasorin Inc.	JJX	Class I	2016-06-30
K161495	ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)	Luminex Corporation	OOI	Class II	2016-06-30
K161247	Relizorb	Alcresta Therapeutics, Inc.	PLQ	Class II	2016-06-30
K160644	Lelo Hex Natural Rubber Latex Condom	Lelo, Inc.	HIS	Class II	2016-06-30
K160441	Identic and KromaFaze Alginate Dental Impression Materials	Sybron Dental Specialties, Inc.	ELW	Class II	2016-06-30
K160235	ViaValve Safety I.V. Catheter	Abbott Medical	FOZ	Class II	2016-06-30
K153749	3 Series Phototherapy Unit	The Daavlin Distributing Co.	FTC	Class II	2016-06-30
K153740	RTHawk, HeartVista Cardiac Package	Heartvista, Inc.	LNH	Class II	2016-06-30
K153689	STERIZONE Sterilizer	Tso3, Inc.	PJJ	Class II	2016-06-30
K153645	VITA ENAMIC Implant Solutions (IS)	Vita Zahnfabrik H.Rauter GmbH & Co.	NHA	Class II	2016-06-30
K153372	Repagyn vaginal suppositories	Farma-Derma S.r.l.	NUC	Class II	2016-06-30
K153177	Admira Fusion Flow	Voco GmbH	EBF	Class II	2016-06-30
K153136	Initial LiSi Press	GC America Inc.	EIH	Class II	2016-06-30
K161285	Ablation Confirmation	Neuwave Medical, Inc.	JAK	Class II	2016-06-29
K161186	Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter)	FUJIFILM Healthcare Americas Corporation	KGE	Class II	2016-06-29
K160901	Xpert Carba-R	Cepheid	POC	Class II	2016-06-29
K160878	OPTIS Metallic Stent Optimization E.4 SW	Lightlab Imaging, Inc.	NQQ	Class II	2016-06-29
K160770	Vent-Os Sinus Dilation family	Sinusys Corporation	LRC	Class I	2016-06-29
K160763	ally Liquid Personal Lubricant	Private Label Production, LLC	NUC	Class II	2016-06-29
K160752	HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm Length	Ethicon Endo-Suregery, LLC	LFL	Unclassified	2016-06-29
K160578	Nustat XR	Beeken Biomedical LLC	QSY	Unclassified	2016-06-29
K160130	BloodSTOP iX Battle Matrix	Lifescience Plus, Inc.	QSY	Unclassified	2016-06-29
K153360	Admire	Siemens Medi Cal Solutions, Inc.	JAK	Class II	2016-06-29
K153273	MySpine Pedicle Screw Placement Guides - LP	Medacta International SA	MNI	Class II	2016-06-29
K152737	Lite Touch	Focus Medical, LLC.	GEX	Class II	2016-06-29
K152501	Spinal Jaxx Interbody Fusion Device	Neuropro Spinaljaxx, Inc.	MAX	Class II	2016-06-29
K151986	ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material	Siemens Healthcare Diagnostics Inc.	CDZ	Class I	2016-06-29
K161479	hipEOS	Onefit Medical	LLZ	Class II	2016-06-28
K161024	Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization Tape	Canadian Technical Tape, Ltd.	JOJ	Class II	2016-06-28
K160926	F1 MPS Modular Pedicle Screw System	Degen Medical	NKB	Class II	2016-06-28
K160916	CoRoent® Ti-C System	Nu Vasive, Incorporated	MAX	Class II	2016-06-28
K160911	Vidas B.r.a.h.m.s. Pct (Pct)	bioMerieux, Inc.	PMT	Class II	2016-06-28
K160874	Nanovis Intervertebral Body Fusion System and FortiCore®	Nanovis, LLC	MAX	Class II	2016-06-28
K160820	PressON Pro Spinal Fixation System	Nexus Spine, L.L.C.	NKB	Class II	2016-06-28
K160697	Gibralt® Spine System and Gibralt® Occipital Spine System	Exactech, Inc.	NKG	Class II	2016-06-28
K160584	Surgical Navigation Advanced Platform (SNAP)	Surgical Theater Inc	LLZ	Class II	2016-06-28
K153739	MRI Patient Monitor TeslaDUO	MIPM Mammendorfer Institut fur Physik und Medizin GmbH	MWI	Class II	2016-06-28
K153393	PowerMidline Catheter	C.R. Bard Inc	PND	Class II	2016-06-28
K153312	Scatter Correction for Cxdi Series	Canon, Inc.	MQB	Class II	2016-06-28
K153078	LED Curing Light GT-2000	Monitex Industrial Co., Ltd.	EBZ	Class II	2016-06-28
K152606	Jeesung Safety Syringe and Single Use Needles	Jeesung Medical Co., Ltd.	MEG	Class II	2016-06-28