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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 425 of 3528

510(k) clearances, page 425 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K192462	syngo.MR Applications	Siemens Medical Solutions USA, Inc.	LLZ	Class II	2020-01-31
K192234	ActiPatch	Bioelectronics Corporation	PQY	Class II	2020-01-31
K192163	TTC Phantom® Intramedullary Nail System	Paragon 28	HSB	Class II	2020-01-31
K191539	1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support	Rapid Biomedical GmbH	MOS	Class II	2020-01-31
K191330	Arc Enterocuff	Boddingtons Plastics, Ltd.	FDA	Class II	2020-01-31
K193339	GTK Veress Needles	Guangzhou T.K Medical Instrument Co., Ltd.	HIF	Class II	2020-01-30
K193060	Noritake Super Porcelain EX-3	Kuraray Noritake Dental, Inc.	EIH	Class II	2020-01-30
K193057	ATTUNE All-Polyethylene Tibia	Depuy Ireland UC	JWH	Class II	2020-01-30
K192941	HySil Super Fast Impression Materials	OSSTEM Implant Co., Ltd.	ELW	Class II	2020-01-30
K192889	Neo	Eemagine Medical Imaging Solutions GmbH	OMA	Class II	2020-01-30
K192397	TruDi Navigation System	Biosense Webster Inc	PGW	Class II	2020-01-30
K192339	TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord	Wilson-Cook Medical Inc.	KNS	Class II	2020-01-30
K191254	EndoClot	Endoclot Plus Co., Ltd.	PLL	Class II	2020-01-30
K190956	Scs 17-01	Anika Therapeutics, Inc.	MQV	Class II	2020-01-30
K190734	Linshom Respiratory Monitoring Device (LRMD)	Linshom Management, LLC	BZQ	Class II	2020-01-30
K193642	Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System	Dexcom, Inc.	QDK	Class II	2020-01-29
K193099	Anatomical Shoulder System	Zimmer GmbH	PHX	Class II	2020-01-29
K193051	LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set	Diasorin Inc.	LSR	Class II	2020-01-29
K192585	Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap	Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC	OAP	Class II	2020-01-29
K191989	WVSM (Wireless Vital Signs Monitor) RWC + miniCap	Athena GTX	MWI	Class II	2020-01-29
K191937	Ezvena IPC, Ezvena SQS	Eezcare Medical Corp.	JOW	Class II	2020-01-29
K191926	VITA VIONIC Bond	Vita Zanhnfabrik H. Rauter GmbH Co.	EBI	Class II	2020-01-29
K191837	UniSmile Clear Aligner System	Vitang Technology LLC	NXC	Class II	2020-01-29
K191677	MectaTap TI Suture Anchor	Medacta International SA	MBI	Class II	2020-01-29
K191498	Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc	Cook Incorporated	LJE	Unclassified	2020-01-29
K191472	Biopsy Needle	Ushare Medical, Inc.	FCG	Class II	2020-01-29
K191380	Quantum® Total Ankle Prosthesis	In2Bones SAS	HSN	Class II	2020-01-29
K191323	Carescape B850	GE Healthcare Finland Oy	MHX	Class II	2020-01-29
K183106	TruAbutment DS	TruAbutment Inc.	NHA	Class II	2020-01-29
K193637	MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System	Compania Mexicana de Radiologia CGR, S.A. de C.V.	KPR	Class II	2020-01-28
K193510	Terason uSmart3200T Ultrasound System	Teratech Corp.	IYN	Class II	2020-01-28
K192581	The NightBlocks Appliance	Advanced Facialdontics, LLC	LQZ	Class II	2020-01-28
K192146	V-Denupet	VITROMED GmbH	MQH	Class II	2020-01-28
K193365	M.U.S.T. Pedicle Screw System	Medacta International SA	NKB	Class II	2020-01-27
K193315	Xenocor Articulating Xenoscope Laparoscope	Xenocor, Inc.	GCJ	Class II	2020-01-27
K192090	CMOS Video Rhino-Laryngoscope SSU	Karl Storz SE & Co. KG	EOB	Class II	2020-01-27
K191715	Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile	STERIS Corporation	OCU	Class II	2020-01-27
K193512	THD Procto Software System	Thd SpA	IYO	Class II	2020-01-26
K193241	Emission Computed Tomography System	Shanghai United Imaging Healthcare Co., Ltd.	KPS	Class II	2020-01-26
K191186	Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode	AD-Tech Medical Instrument Corp.	GYC	Class II	2020-01-25
K193454	IQon Spectral CT	Philips Medical Systems Nederland B.V.	JAK	Class II	2020-01-24
K193263	Reprocessed Achieve Catheter Connecting Cable	Innovative Health, LLC.	NLH	Class II	2020-01-24
K193261	FlightPlan for Embolization	GE Medical Systems SCS	LLZ	Class II	2020-01-24
K193246	Stat Profile Prime Plus Analyzer System	Nova Biomedical Corporation	CHL	Class II	2020-01-24
K193223	Persona Personalized Knee System	Zimmer GmbH	JWH	Class II	2020-01-24
K193109	MRCAT brain	Philips Medical Systems MR Finland	MUJ	Class II	2020-01-24
K192984	APTUS Clavicle System	Medartis AG	HRS	Class II	2020-01-24
K192859	CareSens S Clear BT Blood Glucose Monitoring System	I-SENS, Inc.	NBW	Class II	2020-01-24
K192641	Gemini Titan Sterilization Wrap	MEDLINE INDUSTRIES, LP - Northfield	FRG	Class II	2020-01-24
K192608	Disposable SpO2 Sensor	Shenzhen Sino-K Medical Technology Co., Ltd.	DQA	Class II	2020-01-24