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 874 of 3530

510(k) clearances, page 874 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K121631	Simple T Nasal Mask	Respironics, Inc.	BZD	Class II	2012-10-05
K121563	Corin Trifit Ts Hip	Corin USA	MEH	Class II	2012-10-05
K120499	Abthera Open Abdomen Negative Pressure Therapy System	Kci USA, Inc. (Kinetic Concepts, Inc.)	OMP	Class II	2012-10-05
K120401	Alamo T	Alliance Partners, LLC	MAX	Class II	2012-10-05
K120093	Btl Elite	BTL Industries, Inc	IMJ	Class II	2012-10-05
K120040	Reprocessed Surgical Electric Instrument	Sterilmed Inc	NUJ	Class II	2012-10-05
K113726	Epoc Chloride Test and Epoc Creatinine Test	Epocal Inc	CGL	Class II	2012-10-05
K113039	Smith & Nephew Radiopaque Trial Necks	Smith & Nephew, Inc.	MEH	Class II	2012-10-05
K122384	Minispir	Mir Medical Intl. Research SRL	BZG	Class II	2012-10-04
K122366	Tryptik Cc Anterior Intersomatic Cervical Cage	Spineart SA	ODP	Class II	2012-10-04
K122231	Xpeed Any Ridge Internal Implant System	Megagen Implant Co., Ltd.	DZE	Class II	2012-10-04
K122044	Sterrad(r) Cyclesure(r) 24 Biological Indicator	Advanced Sterilization Products	FRC	Class II	2012-10-04
K122023	Mixject with Spray Head	West Pharma. Services IL, Ltd.	FMF	Class II	2012-10-04
K122012	Z-Med Z-Med II	Numed Inc	OZT	Class II	2012-10-04
K121682	Active Screw Bone Screw	Intelligent Implant Systems, LLC	HWC	Class II	2012-10-04
K121047	Hero II Dental Implant System, Is Dental Implant System	KJ Meditech Co., Ltd.	DZE	Class II	2012-10-04
K120706	Nirvana a Personal Lubricant	Church & Dwight Co., Inc.	NUC	Class II	2012-10-04
K120110	Elegant Nitrile Powder Free Examination Glove Blue Violet	Profit Point Manufacturing Sdn Bhd	LZA	Class I	2012-10-04
K122862	Cd Horizon Spinal System	Medtronic Sofamor Danek USA Inc	NKB	Class II	2012-10-03
K122858	Eltech Chinical System Amylase Sl Elitech Clinical Systems Elical2 Eltech Clinical Systems Elitrol I and Elitrol II	ELITechGroup Inc	JFJ	Class II	2012-10-03
K122737	Geminus Fossa Specific Plate System	Skeletal Dynamics, Inc	HRS	Class II	2012-10-03
K122599	Advia Chemistry Myoglobin Reagent, Advia Chemistry Myoglbin Calibrator	Siemens Healthcare Diagnostics Inc.	DDR	Class II	2012-10-03
K122450	Mhi-Tm2000 Linear Accelerator System Vero Imavis	Mitsubishi Heavy Industries, Ltd.	IYE	Class II	2012-10-03
K122228	Ligafix Interference Screw	Sbm Sciences for Bio Materials	MAI	Class II	2012-10-03
K122114	Logiq S7 Expert, Logiq S7 Pro	GE Healthcare	IYN	Class II	2012-10-03
K122009	Aida Vi.8 Diagnostic Ultrasound Gm-72P00a, L13-5V1 Transducer	Panasonic Healthcare Co., Ltd.	IYN	Class II	2012-10-03
K121579	Ek Delivery Device	Tdak Medical, Inc.	OTZ	Class I	2012-10-03
K121287	Ht-Wedge	D.T. Davis Enterprises Ltd. T/A Hovertech Int'L	FNG	Class II	2012-10-03
K120951	Smartbuilder System	OSSTEM Implant Co., Ltd.	JEY	Class II	2012-10-03
K120751	Nirvana B Personal Lubricant	Church & Dwight Co., Inc.	NUC	Class II	2012-10-03
K120125	Soft-Cuf, Classic-Cuf, Dura-Cuf, Sensa-Cuf	GE Medical Systems Information Technologies, Inc.	DXQ	Class II	2012-10-03
K113650	Orthofix Screw	Bonafix Surgical and Dental Implants, LLC	OAT	Class II	2012-10-03
K111519	Sterrad Sealsure Chemical Indicator Tape Model 14202	Advanced Sterilization Products	JOJ	Class II	2012-10-03
K111518	Sterrad Chemial Indicator Strip Model 14100	Advanced Sterilization Products	JOJ	Class II	2012-10-03
K122756	Penumbra Pump Max (110Vac), Penumbra Pump Max (230Vac), Penumbar Pump Max Canister/tubing	Penumbra Inc.	JCX	Class II	2012-10-02
K122619	Epix Irrigation Pump, Epix Suction Irrigation Tubing Set	Applied Medical	BTA	Class II	2012-10-02
K122267	Giraffe and Panda Warmers	GE Healthcare	FMT	Class II	2012-10-02
K122133	Airstrip Remote Patient Monitoring (Rpm) Remote Data Viewing	AirStrip Technologies, Inc.	MWI	Class II	2012-10-02
K122123	6-8Mm X 30 Mm Intrafix Peek Tapered Screw 7-9Mm X 30Mm Intrafix Peek Tapered Screw 8-10Mm X 30 Mm Intrafix Peek Tapered	DePuy Mitek, Inc.	MBI	Class II	2012-10-02
K121700	Ulthera System	Merz North America, Inc.	OHV	Class II	2012-10-02
K121597	Eson Nasal Mask	Fisher & Paykel Healthcare, Inc.	BZD	Class II	2012-10-02
K121457	Speedicath Compact Set (12 Fr)	MEDLINE INDUSTRIES, LP - Northfield	GBM	Class II	2012-10-02
K121411	Shiga Toxin Chek	Techlab Inc., Corporate Research Center	GMZ	Class I	2012-10-02
K121364	Shiga Toxin Quik Chek	Techlab Inc., Corporate Research Center	GMZ	Class I	2012-10-02
K120148	Aos Solid Locking Lag Screw, Aos Telescoping Lag Screw	Advanced Orthopaedic Solutions, Inc.	HSB	Class II	2012-10-02
K122511	Endopath Xcel Bladeless Trocar with Optiview Technology Endopath Xcel Blunt Tip Trocar with Optiview Technology Endopath	Ethicon Endo-Surgery Inc	GCJ	Class II	2012-10-01
K122308	Axsos Distal Lateral Femur Ts Long Plates	Howmedica Osteonics Corp., dba Stryker Orthopaedics	HRS	Class II	2012-10-01
K122226	Revere Stabilization System	Globus Medical, Inc.	NKB	Class II	2012-10-01
K121684	Novation Lpi Prime Femoral Stem	Exactech, Inc.	LPH	Class II	2012-10-01
K121672	Aft Proximal Humerus Fracture Plate	Shoulder Options, Inc.	HRS	Class II	2012-10-01