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 1033 of 3531

510(k) clearances, page 1033 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K093629	Solitaire and Solitaire Peek Anterior Spinal System	Highridge Medical, LLC	OVD	Class II	2010-03-09
K092817	Poc-As10 Auto Sampler	Otsuka Pharmaceutical Co., Ltd.	MSQ	Class I	2010-03-09
K092435	Verseo Air Pressure Massager	The American Export Group & International Services	IRP	Class II	2010-03-09
K082855	Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses	Menicon Co. Ltd.	MRC	Class II	2010-03-09
K100020	Dx Series Finger Sensor	Dixtal Medical, Inc.	DQA	Class II	2010-03-08
K093788	Infinity Acute Care System (Iacs) Monitoring Solution	Draeger Medical Systems, Inc.	MHX	Class II	2010-03-08
K093585	Microcyn Skin and Wound Hydrogel	Sonoma Pharmaceuticals, Inc.	FRO	Unclassified	2010-03-08
K100446	Circuflow 5100 Sequential Compression Device	Devon Medical, Inc.	JOW	Class II	2010-03-05
K100402	Site-Rite Vision Ultrasound System	Bard Access Systems, Inc.	IYN	Class II	2010-03-05
K100328	Clearfil Majety Posterior	Kuraray Medical, Inc.	EBF	Class II	2010-03-05
K100058	Powder Free Vinyl Patient Examination Gloves, Colored (Yellow)	Tangshan Zhongpu Plastic Products Co., Ltd.	LYZ	Class I	2010-03-05
K094017	Tibial Baseplate Augment Model Kc-22118, Kc-22128, Kc-22138, Kc-22148, Kc-22158	Omni Life Science, Inc.	JWH	Class II	2010-03-05
K093969	Acuity Break-Away Guide Catheter	Cardiac Pacemakers, Inc.	DQY	Class II	2010-03-05
K093943	Biosure Sync Tibial Fixation Device, 6Mm, 8Mm,10mm,12mm	Smith & Nephew, Inc.	MBI	Class II	2010-03-05
K093842	1.5T and 3.0T General Purpose Flex Coils	Invivo Corporation	MOS	Class II	2010-03-05
K093761	Optilock Vl (Variable Angle Locking) Distal Radius Plating System	Biomet Trauma (Aka Ebi, LP)	HRS	Class II	2010-03-05
K093677	Stryker Arthroscope	Stryker Corp.	HRX	Class II	2010-03-05
K093645	Exl Anem Cal, Model Rc640	Siemens Healthcare Diagnostics Inc.	JIX	Class II	2010-03-05
K093624	Optiscan Model Optiscan Ceis	Optiscan Pty., Ltd.	GCJ	Class II	2010-03-05
K093575	Gluma Desensitizer Power Gel	Kulzer GmbH	LBH	Class II	2010-03-05
K093480	Cuattro Unomd	Cuattro Imaging, LLC	LLZ	Class II	2010-03-05
K093380	Mizzy Express	Mycone Dental Supply Co., Inc.	EBG	Class II	2010-03-05
K093336	Integrated Stimulus Delivery System Optimum and Premium	Medical Numerics, Inc.	LNH	Class II	2010-03-05
K093324	Empi Continuum	Empi	IPF	Class II	2010-03-05
K092940	Coaguchek Xs Plus Pst System	Roche Diagnostics GmbH	GJS	Class II	2010-03-05
K092907	Digital Ultrasound Imaging System, Convex Array Transducer, Linear Array Transducer, Convex Array Transducer, Phased Arr	Shantou Institute of Ultrasonic Instuments	IYN	Class II	2010-03-05
K092740	Architect Folate Reagents, Architect Folate Calibrators, and Architect Folate Controls, Models 1P74, 1P74, 1P74	Abbott Medical	CGN	Class II	2010-03-05
K092538	Refine Support System, Model 100.0100	Alure Medical, Inc.	FTL	Class II	2010-03-05
K092460	Star-Lite -Lm, Model Sl8809	Ps Advanced Engineering	OHS	Class II	2010-03-05
K092424	P-Art, Model 001	P-Cure, Ltd.	IYE	Class II	2010-03-05
K092326	Smoothcool	Jeisys Medical Inc.	ONF	Class II	2010-03-05
K092211	Chesapeake Spinal System	K2M, Inc	OVD	Class II	2010-03-05
K090753	Theratest El-Anti-Ccp/2	Theratest Laboratories, Inc.	NHX	Class II	2010-03-05
K090123	Neonatal Biotinidase Kit, Model 3018	Revvity Health Sciences, Inc.	NAK	Class II	2010-03-05
K090050	Stereos Workstation	Biospace Med	LLZ	Class II	2010-03-05
K100297	Pass Lp Spinal System	Medicrea Technologies	MNI	Class II	2010-03-04
K100016	Avita Scaneo Infrared Ear Thermometer, Model Ts7	Avita Corporation	FLL	Class II	2010-03-04
K093897	Smith & Nephew Footprint Ultra Pk Suture Anchor	Smith & Nephew, Inc.	MBI	Class II	2010-03-04
K093702	Reprocessed Ultrasonic Coagulating Shears	Stryker Sustainability Solutions	NLQ	Unclassified	2010-03-04
K093700	Elecsys Hcg Stat Calcheck 5	Roche Diagnostics GmbH	JJX	Class I	2010-03-04
K093615	Spi Dental Implant, Element	Thommen Medical AG	DZE	Class II	2010-03-04
K093612	Syngo.plaza	Siemens AG Medical Solutions	LLZ	Class II	2010-03-04
K093576	Rubber-Like Powder Free Vinyl Patient Examination Gloves, White Color	Jiangsu Cureguard Glove Co., Ltd.	LYZ	Class I	2010-03-04
K093552	Evolution Mp Total Knee System	Wrightmedicaltechnologyinc	JWH	Class II	2010-03-04
K093523	Micro-Touch Nitrile	Ansell Healthcare Products LLC	LZA	Class I	2010-03-04
K093508	Rigid Cannulae Curved (Rc6-Rc12), Rigid Cannulae Straight (Rs6-Rs12)	Womancare Global	HGH	Class II	2010-03-04
K093388	Smart Capnoline Guardian	Oridion Medical 1987 Ltd.	CCK	Class II	2010-03-04
K093306	Single-Patient Use Disposable Sensor	Nonin Medical, Inc	DQA	Class II	2010-03-04
K093210	Aqualase Capsule Wash Tip	Alcon Manufacturing, Ltd.	HQC	Class II	2010-03-04
K093127	Trabecular Metal (Tm) Vertebral Body Replacement (Vbr) System Instrument Set	Zimmer Trabecular Metal Technology, Inc.	MQP	Class II	2010-03-04