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 981 of 3531

510(k) clearances, page 981 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K103256	Smith & Nephew Smf Hip Stem	Smith & Nephew, Inc.	LPH	Class II	2011-01-31
K103254	Peristeen Anal Irrigation System, Irrigation Accessory Unit, Irrigation Rectal Catheter, System Strap, Irrigation Tube	MEDLINE INDUSTRIES, LP - Northfield	KNT	Class II	2011-01-31
K103208	Reverse Shoulder Prosthesis Monoblock Stem	Encore Medical, LP	PHX	Class II	2011-01-31
K102924	Aequalis Ascend Modular Anatomic Shoulder System	TORNIER Inc.	KWS	Class II	2011-01-31
K102369	Piccolo Composite Nailing System	N.M.B. Medical Applications, Ltd.	HSB	Class II	2011-01-31
K110077	Neucoloncare	Neusoft Medical Systems Co., Ltd.	LLZ	Class II	2011-01-28
K103014	Miradry System	miraDry, Inc.	OUB	Class II	2011-01-28
K103009	Senticare Pillstation	Senticare, Inc.	NXQ	Class I	2011-01-28
K102884	Sterrad Cyclesure 24 Biological Indicator	Advanced Sterilization Products	FRC	Class II	2011-01-28
K102824	Ambu Oval Silicone Resuscitator, Adult and Pediatric	Ambu A/S	BTM	Class II	2011-01-28
K102664	Hema Screen Er	Immunostics, Inc.	KHE	Class II	2011-01-28
K102621	Solstice	Sybron Dental Specialties, Inc.	EBZ	Class II	2011-01-28
K102319	Compressible Limb and Circulation Therapy System Model Wic-2008	Won Industrial Co.	IRP	Class II	2011-01-28
K101454	Mammaprint	Agendia Inc	NYI	Class II	2011-01-28
K101263	Lima-Lto Smr Shoulder System - Finned Humeral Stems, Lima-Lto Smr Shoulder System - Finned Humeral Bodies,	Lima-Lto S.p.A.	KWT	Class II	2011-01-28
K101136	Fisio Chamber Space	Koo (Shanghai) Industries Co., Ltd	NVP	Class II	2011-01-28
K101016	Ans System	Caird Technology	DPS	Class II	2011-01-28
K103782	4D Mv-Assessment 2.0	TOMTEC Imaging Systems GmbH	DQK	Class II	2011-01-27
K103297	Redondo-L	Seaspine, Inc.	MAX	Class II	2011-01-27
K102722	Norian Drillable Inject, Norian Drillable Fast Set Putty	Synthes (USA) Products LLC	MQV	Class II	2011-01-27
K102363	Spsmedical Emplus 270 F Steam Emulator Model Emp-104, Emp-1004	Spsmedical Supply Corp.	JOJ	Class II	2011-01-27
K101459	Osteoraptor II Suture Anchor or to Be Determined Model: 72202764 72202765 72202766 72202767 72202768 72202769 72202770	Smith & Nephew, Inc.	MAI	Class II	2011-01-27
K101346	Gc Oral Moisturizing Gel	GC America Inc.	LFD	Unclassified	2011-01-27
K093617	Ventlab 6000 Series Humidifier	Salter Labs	BTT	Class II	2011-01-27
K092025	Fluid Filled Teether - Gel	Kids II, Inc.	KKO	Class II	2011-01-27
K110085	Vantage View System	Abbott Medical	DXJ	Class II	2011-01-26
K110048	Cersr Electromyography System	Spinematrix, Inc.	IKN	Class II	2011-01-26
K110040	Omnivision	Modern Module, Inc.	LLZ	Class II	2011-01-26
K110004	Asc Triport+ Laparoscopic Access Device	Advanced Surgical Concepts	OTJ	Class II	2011-01-26
K103800	Braun Thermoscan Pro 4000 Series and Braun Thermoscan Irt 4000 Series Clinical Infrared Ear Thermometers	Kaz USA, Inc (A Subsidiaryof Kaz Inc)	FLL	Class II	2011-01-26
K103780	Micrus Ascent Occlusion Balloon Catheter 4X7 Mm; Micrus Ascent Occlusion Balloon Catheter 6X9 Mm; Micrus Summit Occlusio	Micrus Endovascular Corporation	MJN	Class II	2011-01-26
K103778	Leforte Neuro System Bone Plate	Jeil Medical Corporation	JEY	Class II	2011-01-26
K103522	Sedecal	Sedecal S.A.	IZL	Class II	2011-01-26
K103305	Penumbra Embolization Coil System	Penumbra Inc.	HCG	Class II	2011-01-26
K103187	Tripleplay-Vt Vascular Therapy System	Wildcat Medical, Inc.	JOW	Class II	2011-01-26
K103176	Frequencer	Dymedso, Inc.	BYI	Class II	2011-01-26
K102927	Consensus Knee System	Consensus Orthopedics, Inc.	MBH	Class II	2011-01-26
K102886	Cd Horizon Spinal System	Medtronic Sofamor Danek	KWP	Class II	2011-01-26
K102792	Disposable Blood Pressure Cuf	Caremate Medical Device Co., Ltd.	DXQ	Class II	2011-01-26
K102101	Surgivision Mr Compatible Ventricular Cannula	Surgivision, Inc.	HCD	Class I	2011-01-26
K101945	Neodent Implant System	Jjgc Industria E Comercio de Materiais Dentarios S	DZE	Class II	2011-01-26
K101807	Stayhealthy Body Composition Monitor-Bcm	Stayhealthy, Inc.	MNW	Class II	2011-01-26
K101643	Model Ltv 1100 Ventilator	Care Fusion	CBK	Class II	2011-01-26
K101628	Kowa Nonmyd Wx	Kowa Co., Ltd.	HKI	Class II	2011-01-26
K103815	Q-Station	Philips North America LLC	LLZ	Class II	2011-01-25
K103805	Medical Wire & Equipment S-Transwab (or Sigma-Transwab) Liquid Amies Collection and Transport Device	Medical Wire & Equipment Company (Bath), Ltd.	LIO	Class I	2011-01-25
K103616	Pinpoint Stereotactic Head and Neck Localizer	Aktina Medical Physics Corp.	IYE	Class II	2011-01-25
K103612	Dimension Visa Enz 2 Cal	Siemens Healthcare Diagnostics Inc.	JIX	Class II	2011-01-25
K103511	Litecure Therapy System	LiteCure, LLC	ILY	Class II	2011-01-25
K103450	Fdi Glucose Control Solution for Freestyle	Fujirebio Diagnostics, Inc.	JJX	Class I	2011-01-25