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 400 of 3528

510(k) clearances, page 400 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K193073	Deep Recon	Shanghai United Imaging Healthcare Co., Ltd.	JAK	Class II	2020-07-06
K191152	MIS Ti-base Abutment	Dentsply Sirona Inc	NHA	Class II	2020-07-06
K200795	LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit	Medtronic, Inc.	MXD	Class II	2020-07-03
K200537	Oxxiom	True Wearables, Inc.	DQA	Class II	2020-07-03
K201633	Terason uSmart 3200T Plus Ultrasound System	Teratech Corp.	IYN	Class II	2020-07-02
K201599	2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+	Shenzhen Beacon Display Technology Co., Ltd.	PGY	Class II	2020-07-02
K201487	Traxcess 7 Mini Guidewire	Terumo Cardiovascular Systems Corporation	MOF	Class II	2020-07-02
K201048	SherpaPak Pediatric Liver Transport System	Paragonix Technologies Inc.	KDN	Class II	2020-07-02
K200947	InMode System with the Morhpeus8 Applicators	Inmode Ltd.	GEI	Class II	2020-07-02
K200894	Agape Cooling Personal Lubricant	CC Wellness LLC	NUC	Class II	2020-07-02
K200766	3M Attest Steam Chemical Integrator Test Pack	3M Company	FRC	Class II	2020-07-02
K200674	AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector	Atrility Medical, Inc.	DSA	Class II	2020-07-02
K200285	VenaOne	Vena Group, LLC	JOW	Class II	2020-07-02
K193484	GC Fuji Triage EP	GC America Inc.	EMA	Class II	2020-07-02
K193259	Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer	Little Doctor Electronic(nantong) Co.,Ltd	DXQ	Class II	2020-07-02
K193252	Contour ProtegeAI	MIM Software Inc	QKB	Class II	2020-07-02
K193172	Luna XD Ti Interbody Fusion System	Benvenue Medical, Inc.	MAX	Class II	2020-07-02
K192880	InferRead Lung CT.AI	Beijing Infervision Technology Co., Ltd.	OEB	Class II	2020-07-02
K192872	ulrichINJECT CT Motion	Ulrich GmbH & Co. KG	IZQ	Class II	2020-07-02
K192411	Psoria-Shield AURORA	Psoria-Shield Inc	FTC	Class II	2020-07-02
K192385	ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable	Ivwatch, LLC	PMS	Class II	2020-07-02
K183471	IC-WHCD100 (Inspire)	Good Doctors Co., Ltd.	NBL	Class II	2020-07-02
K201477	syngo.via View&GO	Siemens Healthcare GmbH	LLZ	Class II	2020-07-01
K201449	SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring	Medtronic, Inc.	KRH	Class II	2020-07-01
K200880	T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon Nail System, T2 Greater Trochanter Nail (GTN),T2 Ankle Arthrodesis Nail,T2 Arthrodesis Nail System	Stryker Corp.	HSB	Class II	2020-07-01
K200561	StimPlus Patch, StimPlus Patch, StimPlus Patch	JKH Health Co., Ltd.	NUH	Class II	2020-07-01
K200248	Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators	Allwin Medical Devices, Inc.	MQF	Class II	2020-07-01
K200138	Versana Premier	GE Medical Systems Ultrasound and	IYN	Class II	2020-07-01
K201464	Altapore MIS	Baxter Healthcare Corporation	MQV	Class II	2020-06-30
K201455	Litho 150, Cyber Ho 150	Quanta System Inc.	GEX	Class II	2020-06-30
K200874	TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End	Innovasis, Inc	FST	Class II	2020-06-30
K200272	Terragene Chemdye	Terragene LLC	JOJ	Class II	2020-06-30
K200265	Surgical Drills	Implant Direct Sybron Manufacturing LLC	DZI	Class II	2020-06-30
K193632	LassoStar Circular Mapping Catheter	Biosense Webster Inc	DRF	Class II	2020-06-30
K192778	Kinos Axiom Total Ankle System	Kinos Medical	HSN	Class II	2020-06-30
K191276	Dental Electrical Motor iRoot Pro	Changzhou Bomedent Medical Technology Co., Ltd	EKX	Class I	2020-06-30
K201507	Cadence Total Ankle System	Integra LifeSciences Corporation	HSN	Class II	2020-06-29
K201503	Edge Air(1417) Digital Flat Panel X-ray Detector	Osko, Inc.	MQB	Class II	2020-06-29
K201423	MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)	Siemens Healthcare Diagnostics Inc.	LTT	Class II	2020-06-29
K201156	ARTIS pheno (VE2)	Siemens Medical Solution USA, Inc.	OWB	Class II	2020-06-29
K200698	Somnera System	Fresca Medical	QBY	Class II	2020-06-29
K200420	Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, Green	Ethicon Endo-Surgery Inc	GDW	Class II	2020-06-29
K200354	Electronic stimulator	Shenzhen Dongjilian Electronics Co., Ltd.	NUH	Class II	2020-06-29
K200068	Arthrex DynaNite K-Wire	Arthrex GmbH	HTY	Class II	2020-06-29
K193119	Twin-Pass Dual Access Catheter	Vascular Solutions LLC	DQY	Class II	2020-06-29
K192900	H500 Multi-Sensing Oximetry System	Nonin Medical, Inc	DQA	Class II	2020-06-29
K200888	OMNIBotics Knee System	Corin, Ltd.	OLO	Class II	2020-06-27
K201373	DRX-Compass	Eastman Kodak Company	KPR	Class II	2020-06-26
K201181	EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System	Abbott Medical	DQK	Class II	2020-06-26
K201164	Venus Viva MD Device	Venus Concept USA Inc.	GEI	Class II	2020-06-26