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 1029 of 3531

510(k) clearances, page 1029 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K091933	Electro-Acupuncture: Aculife/model Idoc-01	Inno-Health Technology Co., Ltd.	BWK	Unclassified	2010-04-02
K091716	Merits Health Products Profil Q601 Series Oxygen Filling Accessory	Merits Health Products, Inc.	CAW	Class II	2010-04-02
K083785	Vitala Continence Control Device	ConvaTec Limited	EZQ	Class I	2010-04-02
K100633	Infinitas Mini-Implant Model: Db10-0009, Db10-0010,Db10-0012,Db10-0015,Db10-0016	D B Orthodontics Ltd	OAT	Class II	2010-04-01
K100594	Elecsys Troponin I Calcheck 5	Roche Diagnostics GmbH	JJX	Class I	2010-04-01
K093869	Se-601 Series Electrocardiograph	Edan Instruments, Inc.	DPS	Class II	2010-04-01
K093844	Smith & Nephew Twinfix Ultra Ha Suture Anchor	Smith & Nephew, Inc.	MAI	Class II	2010-04-01
K093506	Clever Choice Auto-Code Pro Blood Glucose Monitoring System Model Td-4267	Taidoc Technology Corporation	CGA	Class II	2010-04-01
K093400	1Ml Unitract Insulin Syringe 27G X 1/2 and 29G X 1/2	Unilife Medical Solutions Limited	FMF	Class II	2010-04-01
K093205	Padcheck	Padtest, LLC	DXN	Class II	2010-04-01
K093010	Mach LED Mc	Dr. Mach GmbH & Co. KG	FSY	Class II	2010-04-01
K093009	Mach LED Sc	Dr. Mach GmbH & Co. KG	FSY	Class II	2010-04-01
K092391	Mobileaed, Mobileals, Mobileaed+ and Advantageaed	Concord Medical Products	MKJ	Class III	2010-04-01
K100575	Ldr Spine USA Spine Tune Tl Spine System	Ldr Spine USA	MNI	Class II	2010-03-31
K100314	Imns Medacta Navigation System,33.221000us	Medacta International SA	HAW	Class II	2010-03-31
K093872	Handheld ECG Monitor, Model Md100	Beijing Choice Electronic Technololgy Co., Ltd.	DPS	Class II	2010-03-31
K100712	Resound Endoscopic Ultrasound Aspiration Needle	Boston Scientific Corporation	FCG	Class II	2010-03-30
K100671	Novabone Dental Putty-Bioactive Synthetic Bone Graft	Novabone Products, LLC	LYC	Class II	2010-03-30
K100641	Intracept Flexible Bi-Polar RF Probe and Easy Access Instrument Set, Model Fg0018 (Probe), Fg0036 (Instrument Set)	Relievant Medsystems	GEI	Class II	2010-03-30
K100615	Arstasis Access System	Arstasis, Inc.	DYB	Class II	2010-03-30
K100559	Myosure Hysteroscopic Tissue Removal System	Interlace Medical, Inc.	HIH	Class II	2010-03-30
K100401	Swerv Magnetostrictive Ultrasonic Scaler System	HU-Friedy Mfg. Co. LLC	ELC	Class II	2010-03-30
K093633	Infinity Acute Care System Workstation Critical Care	Draegerwerk AG & Co. KGaA	CBK	Class II	2010-03-30
K093494	Linasys Image-Guided Liver Surgery System	Pathfinder Therapeutics, Inc.	OEW	Class II	2010-03-30
K093016	Vital Signs Monitor	Shenzhen Creative Industry Co., Ltd	DQA	Class II	2010-03-30
K092849	Blood Collection Tube Samples for Use with Point of Care Blood Analyzer	Epocal Inc	CEM	Class II	2010-03-30
K092448	Hivox Electric Stimulator TENS & Ems, Hd2	Hivox Biotek Inc.	GZJ	Class II	2010-03-30
K091313	Sysmex Model Xt-4000I	Sysmex America, Inc.	GKZ	Class II	2010-03-30
K100722	Telavancin 30 Ug, Bbl Sensi-Disc	Becton Dickinson & Co	JTN	Class II	2010-03-29
K100555	Apex-Lnk Acetabular Insert, E, Apex-Lnk Acetabular Insert, F, Apex-Lnk	Omni Life Science, Inc.	LPH	Class II	2010-03-29
K100337	Powder-Free Vinyl Patient Examination Gloves	Tangshan Qixin Glove Co., Ltd.	LYZ	Class I	2010-03-29
K100324	Powder-Free Vinyl Patient Examination Gloves	Tangshan Hengtong Plastic Products Co.	LYZ	Class I	2010-03-29
K100270	Artisan Aesthetic System	Palomar Medical Technologies, Inc.	GEX	Class II	2010-03-29
K100236	Stair Systems Pacs & Dicom Viewer	Stair Systems, Inc.	LLZ	Class II	2010-03-29
K093928	Synthes 3.5Mm Quadrilateral Surface Plates	Synthes (USA) Products LLC	HRS	Class II	2010-03-29
K093772	Synthes Sternal Fixation System	Synthes GmbH	HRS	Class II	2010-03-29
K093582	Elecsys Ck-Mb Calcheck 5	Roche Diagnostics GmbH	JJX	Class I	2010-03-29
K092493	Gpc Bone Plaes and Bone Screw & Gpc Dhs/dcs Plate System	GPC Medical Limited	HRS	Class II	2010-03-29
K091616	Bioplex 2200 Mmrv Igg	Bio-Rad Laboratories Inc.	OPL	Class II	2010-03-29
K100579	G-Force Ti Suture Anchor System	Wrightmedicaltechnologyinc	MBI	Class II	2010-03-26
K100527	Hoveround Teknique, Model Hd-6	Hoveround Corp.	ITI	Class II	2010-03-26
K100062	Infiltration Kit	Dmg USA, Inc.	EBC	Class II	2010-03-26
K093941	Clever Choice Mini Blood Glucose Monitoring System Model Td-4265	Taidoc Technology Corporation	CGA	Class II	2010-03-26
K093776	Indus Anterior Cervical Plate System	SPINEFRONTIER, Inc. dba LESspine Innovations	KWQ	Class II	2010-03-26
K093524	Pivit A/b St and Pivit A/b St-R	Tyrx, Inc.	FTL	Class II	2010-03-26
K093261	Moves	Thornhill Research Inc	BTL	Class II	2010-03-26
K093257	Torqmax Sheath Grip Accessory	Spectranetics Corp.	OFC	Class II	2010-03-26
K092061	Forecare Advanced Sport Wrist Blood Pressure Monitor, Model Fp-0217	Genexel Medical Instrument, Inc.	DXN	Class II	2010-03-26
K091940	Magpro, Models R30 with Magoption, X100, X100 with Magoption	Tonica Elektronik a/S	GWF	Class II	2010-03-26
K100510	Ceramir Crown & Bridge	Doxa AB	EMA	Class II	2010-03-25