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 447 of 3528

510(k) clearances, page 447 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K182631	SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP)	Eurogreen International, Inc.	INI	Class II	2019-09-19
K192254	InnoSight Diagnostic Ultrasound System	Qisda Corporation	IYN	Class II	2019-09-18
K192065	Syngo.Via RT Image Suite	Siemens Medical Solutions USA, Inc.	MUJ	Class II	2019-09-18
K191663	Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0	Canon Medical Systems Corporation	IYN	Class II	2019-09-18
K191552	GM501 Mineral Oil	HAMILTON THORNE, Inc.	MQL	Class II	2019-09-18
K191457	BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)	Med-el Elektromedizinische Geraete, GmbH	PFO	Class II	2019-09-18
K191391	HEDRON Lumbar Spacers	Globus Medical, Inc.	MAX	Class II	2019-09-18
K191357	Flexible HD Cysto-Urethroscope System	Karl Storz Endoscopy-America, Inc.	FAJ	Class II	2019-09-18
K191232	AccuCath Ace Intravascular Catheter	C.R. Bard Inc	FOZ	Class II	2019-09-18
K191187	Dornier MINNOW Ureteral Catheter	Dornier Medtech America, Inc.	EYB	Class II	2019-09-18
K191113	geko T-2 and geko T-3 Neuromuscular Stimulators	Firstkind Ltd	IPF	Class II	2019-09-18
K190858	Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant	United Consortium	NUC	Class II	2019-09-18
K190563	4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage	Solco Biomedical Corp.	MAX	Class II	2019-09-18
K183436	OraCure	Tbm Corporation	OLR	Unclassified	2019-09-18
K183103	EMS Belt (Model MC0485)	Dongguan Yingfeng Metal & Plastic Products Co., Ltd	NGX	Class II	2019-09-18
K182292	VORTRAN APM-Plus	Vortran Medical Technology 1, Inc	CAP	Class II	2019-09-18
K192059	Bio Guard Air/Water & Suction Valves	United States Endoscopy Group, Inc.	ODC	Class II	2019-09-17
K192037	Advisor VL Circular Mapping Catheter, Sensor Enabled	Abbott Medical	DRF	Class II	2019-09-17
K191947	VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Return Cord	Maquet Cardiovascular LLC	GEI	Class II	2019-09-17
K191929	UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens	Unicon Optical Co., Ltd.	LPL	Class II	2019-09-17
K191842	Discovery Pico, Discovery Pico Plus, Discovery Pico Derm	Quanta System Inc.	GEX	Class II	2019-09-17
K191297	iNSitu Bipolar Hip System	Theken Companies LLC	KWY	Class II	2019-09-17
K191253	Reusable NIBP Cuff	Shenzhen Changke Connect Electronics Co., Ltd.	DXQ	Class II	2019-09-17
K191243	HEDRON Cervical Spacers	Globus Medical, Inc.	ODP	Class II	2019-09-17
K190308	Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1)	AMD Medicom Inc.	OXZ	Class II	2019-09-17
K190049	Sim&Size	Sim&cure	PZO	Class II	2019-09-17
K183708	Poly Clear	Medtek Skincare, LLC	OLP	Class II	2019-09-17
K181416	Sapphire Dorsal Comfort Fit	Crane Dental Laboratory	LRK	Class II	2019-09-17
K191800	Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim, Sterile Powder Free Nitrile Examination Glove, White Colored, with Non-Pyrogenic Labeling Claim	Kossan International Sdn Bhd	LZA	Class I	2019-09-16
K191688	SubtleMR	Subtle Medical Inc	LLZ	Class II	2019-09-16
K191685	PicoWay Laser System	Candela Corporation	GEX	Class II	2019-09-16
K191676	Intra.Ox 2.0 Handheld Tissue Oximeter	Vioptix, Inc.	MUD	Class II	2019-09-16
K191641	AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius Plates, AFFINITY – Variable Angle Distal Radius Screws	Industrias Medicas Sampedro S.A.S	HRS	Class II	2019-09-16
K191576	Mercury® Spinal System, Overwatch® Spinal System	Spinal Elements, Inc	NKB	Class II	2019-09-16
K190708	AccelFix Lumbar Interbody Fusion Cage System	L&K Biomed Co.,Ltd.	MAX	Class II	2019-09-16
K190507	Full Automatic (NIBP) Blood Pressure Monitor	Health & Life Corporation	DXN	Class II	2019-09-16
K191378	0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe	MEDLINE INDUSTRIES, LP - Northfield	NGT	Class II	2019-09-15
K192304	SIS Software Version 3.6.0	Surgical Information Sciences, Inc.	LLZ	Class II	2019-09-13
K192217	NCB Plating System Distal Femur and Proximal Tibia	Zimmer GmbH	HRS	Class II	2019-09-13
K191949	UNFOLDER Vitan Inserter	Advanced Medical Optics, Inc.	MSS	Class I	2019-09-13
K191801	Probeat-Cr	Hitachi, Ltd.	LHN	Class II	2019-09-13
K191599	NICO Myriad NOVUS	Nico Corporation	GEI	Class II	2019-09-13
K191595	ARCHITECT STAT High Sensitivity Troponin-I	Abbott Laboratories Diagnostics Division	MMI	Class II	2019-09-13
K191459	JuggerStitch Meniscal Repair Device	Zimmer GmbH	MBI	Class II	2019-09-13
K191273	Multi-Link X2 ECG and SpO2 Adapter	Jaeger Medical GmbH	DSA	Class II	2019-09-13
K191021	Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye	Terragene LLC	FRC	Class II	2019-09-13
K190932	RFID Localization System	Health Beacons, Inc.	NEU	Class II	2019-09-13
K190869	Pulse Oximeter	Shenzhen Aeon Technology Co.,Ltd	DQA	Class II	2019-09-13
K190841	SCENARIA View	FUJIFILM Healthcare Americas Corporation	JAK	Class II	2019-09-13
K190830	TDM Screw Systems	Tdm Co., Ltd.	HWC	Class II	2019-09-13