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 2026-10-19, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 508 of 3529

510(k) clearances, page 508 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K182230	Multi Modality Viewer	Canon Medical Informatics, Inc.	LLZ	Class II	2018-09-07
K182208	syngo.via View&GO (Version VA10A)	Siemens Healthcare GmbH	LLZ	Class II	2018-09-07
K182148	SILVERBACK Gorilla Plating System	Paragon 28	HWC	Class II	2018-09-07
K182147	Ctxx85	Analogic Corp.	JAK	Class II	2018-09-07
K182144	Bi-Flex Evo	Promepla S.A.M	KNY	Class II	2018-09-07
K182079	Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask	Medtec Inc. dba Civco Medical Solutions	IYE	Class II	2018-09-07
K182053	Ultravision™ Visual Field Clearing System	Alesi Surgical Ltd	PQM	Class II	2018-09-07
K181811	ReTrace Ureteral Access Sheath	MEDLINE INDUSTRIES, LP - Northfield	FED	Class II	2018-09-07
K181688	R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator	Shenzhen Roundwhale Technology Co. Ltd.	IPF	Class II	2018-09-07
K181537	Glow800	Leica Microsystems (Schweiz) AG	IZI	Class II	2018-09-07
K181525	INNOVANCE Free PS Ag	Siemens Healthcare Diagnostics Products Limited	GGP	Class II	2018-09-07
K181423	AMSure Sterile Water, and Sterile Normal Saline for Wound Flush	Amsino International, Inc.	FRO	Unclassified	2018-09-07
K181311	Philips Hemodynamic Application R1.0	Philips Medical Systems Nederland B.V.	MWI	Class II	2018-09-07
K181270	Disposable SpO2 Sensors, Reusable SpO2 Sensors	Orantech Inc.	DQA	Class II	2018-09-07
K181061	Corin Optimized Positioning System (OPS) Femoral	Corin USA	LZO	Class II	2018-09-07
K180778	Exceed Microneedling Device	Mt. Derm GmbH	QAI	Class II	2018-09-07
K173883	External Fixation System	Life Spine	KTT	Class II	2018-09-07
K173813	IPL Hair Removal Device Joy Version	Shen Zhen Cosbeauty Co., Ltd.	OHT	Class II	2018-09-07
K170702	mediCAD 4.0	mediCAD HECTEC GmbH	LLZ	Class II	2018-09-07
K182234	Optima XR240amx	GE Healthcare	IZL	Class II	2018-09-06
K182153	Ultrasound System SONIMAGE HS1	Konica Minolta, Inc.	IYO	Class II	2018-09-06
K181558	Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact Lens, Sofclear Comfort (methafilcon A) Daily Wear Contact Lens	Gelflex Laboratories	LPL	Class II	2018-09-06
K181518	Sebacia Microparticles	Sebacia, Inc.	QCY	Class II	2018-09-06
K181128	Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System)	Contego Medical, Inc	LIT	Class II	2018-09-06
K180728	Spinal Elements Cerclage System	Spinal Elements, Inc	OWI	Class II	2018-09-06
K180465	Provata Implant System	Southern Implants, (Pty.) Ltd.	DZE	Class II	2018-09-06
K173893	Trabis	Coligne AG	PLR	Class II	2018-09-06
K172834	Dual output digital therapy massager	Shenzhen Osto Technology Company Limited	NUH	Class II	2018-09-06
K182138	Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD	Eleckta Limited	IYE	Class II	2018-09-05
K181878	Kiierr 272 Laser, Kiierr 148 Laser	Kiierr International LLC	OAP	Class II	2018-09-05
K181662	Iridex TruFocus LIO Premiere	Iridex Corporation	GEX	Class II	2018-09-05
K173976	Masimo Acoustic Respiration Sensors, infant and neonate	Masimo Corporation	BZQ	Class II	2018-09-05
K173921	HD-500 Video Endoscope System	Sonoscape Medical Corp.	NWB	Class II	2018-09-05
K173665	AMSafe Sure-Lok Needle-Free Connector	Amsino International, Inc.	FPA	Class II	2018-09-05
K181814	AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water	Amsino International, Inc.	EZL	Class II	2018-09-04
K181532	Exactech Alteon Monobloc Revision Stem	Exactech, Inc.	LZO	Class II	2018-09-04
K181510	Echolaser X4	El.en. Electronic Engineering SpA	GEX	Class II	2018-09-04
K181314	IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension	Philips Medizin Systeme Boeblingen GmbH	MHX	Class II	2018-09-04
K181249	EUSRA RF Electrode	Starmed Co.,Ltd	GEI	Class II	2018-09-04
K173765	Surveyor Patient Monitor	Mortara Instrument, Inc.	MHX	Class II	2018-09-04
K173568	NeoBase 2 Non-derivatized MSMS Kit	Wallac Oy, Subsidiary of Perkinelmer	NQL	Class II	2018-09-04
K181167	Upcera Glaze Paste, Glaze Powder, and Glaze Liquid	Liaoning Upcera Co.,Ltd	EIH	Class II	2018-09-02
K181466	Cadwell Zenith System	Cadwell Industries Inc	GWQ	Class II	2018-09-01
K182107	CarriGen PF	Etex Corp.	MQV	Class II	2018-08-31
K181543	Cure™ OPEL-C Plate System	Meditech Spine, LLC	KWQ	Class II	2018-08-31
K181482	myTAP2	Airway Management Inc.	LRK	Class II	2018-08-31
K181464	LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set	Diasorin Inc.	LYR	Class I	2018-08-31
K181228	IlluminOss Bone Stabilization System	Illuminoss Medical Inc.	QAD	Class II	2018-08-31
K181225	Altapore	Baxter Healthcare Corporation	MQV	Class II	2018-08-31
K180866	CareSens S Fit Blood Glucose Monitoring System	I-SENS, Inc.	NBW	Class II	2018-08-31