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 428 of 3528

510(k) clearances, page 428 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K192429	Dental Pain Eraser	Synapse Dental	LWM	Unclassified	2020-01-14
K192115	SABLE Expandable Spacer	Globus Medical, Inc.	MAX	Class II	2020-01-14
K191020	G210 InviCell Plus with SignipHy pH monitoring	CooperSurgical, Inc.	PUB	Class II	2020-01-14
K190316	Icare ic200	Icare Finland Oy	HKY	Class II	2020-01-14
K193645	nva, nvp, and nvt	Nvision Biomedical Technologies, Inc	MAX	Class II	2020-01-13
K192544	Erchonia Emerald	Erchonia Corporation	OLI	Class II	2020-01-13
K192409	Midwest Rhino XE and Air Motor M	Dentsply Sirona Inc	EFB	Class I	2020-01-13
K191717	Route 92 Medical Sheath System	Route 92 Medical, Head Quarters	DQY	Class II	2020-01-13
K183074	TENS and EMS Stimulator, TENS Stimulator	Astek Technology Ltd.	IPF	Class II	2020-01-11
K193465	CorticaLINK Spinal Fusion Platform	Spine Smith Partners L.P.	NKB	Class II	2020-01-10
K193452	MotoBAND CP Implant System	Crossroads Extemity Systems, LLC	HRS	Class II	2020-01-10
K193372	Univers Revers Modular Glenoid System (Augemented baseplates)	Arthrex GmbH	PHX	Class II	2020-01-10
K193011	CD Horizon™ Fenestrated Screw Set	Medtronic Sofamor Danek USA Inc	NKB	Class II	2020-01-10
K192995	OsteoRemedies Hip Spacer System	Osteoremedies, LLC	KWL	Class II	2020-01-10
K192966	FlowMet	Laser Associated Sciences, Inc.	DPW	Class II	2020-01-10
K192315	Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs)	MEDLINE INDUSTRIES, LP - Northfield	LZA	Class I	2020-01-10
K192307	Nihon Kohden NKV-550 Series Ventilator System	Nihon Kohden Orangemed, LLC	CBK	Class II	2020-01-10
K191692	KardioScreen	Imedrix Inc. (Formerly Piitech Inc.)	DPS	Class II	2020-01-10
K191678	IP Converter	Sony Electronics Inc.	GCJ	Class II	2020-01-10
K191221	Cybird LED Curing Light	Dxm Co., Ltd.	EBZ	Class II	2020-01-10
K190878	Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff, Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff	Salter Labs	BTR	Class II	2020-01-10
K193440	ER-REBOA PLUS Catheter	Prytime Medical Devices, Inc.	MJN	Class II	2020-01-09
K193433	AMIStem-C	Medacta International SA	LZO	Class II	2020-01-09
K192975	Tyber Medical Trauma Screws	Tyber Medical	HWC	Class II	2020-01-09
K192687	TrellOss™-L MPF	Nexxt Spine LLC	MAX	Class II	2020-01-09
K192363	Altapore	Baxter Healthcare Corporation	MQV	Class II	2020-01-09
K192009	LED Curing Light	Ezgo Group, Inc.	EBZ	Class II	2020-01-09
K191210	Longeviti ClearFit Cranial Implant	Longeviti Neuro Solutions	GXN	Class II	2020-01-09
K191052	HyaloGYN Vaginal Moisturizing Suppositories	Fidia Farmaceutici S.P.A	NUC	Class II	2020-01-09
K193137	EASYGRIP FLO-41 Precision MIS Delivery System	Baxter Healthcare Corportation	GCJ	Class II	2020-01-08
K193024	Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/mL	Thermo Fisher Scientific Oy	JWY	Class II	2020-01-08
K192974	Tyber Medical Trauma Screw	Tyber Medical	HWC	Class II	2020-01-08
K192767	Clear Aligner	Royal Dental Lab	NXC	Class II	2020-01-08
K191581	Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device	Titan Spine, LLC	OVD	Class II	2020-01-08
K191489	Genesys Spine 3DP Cervical Interbody System	Genesys Spine	OVE	Class II	2020-01-08
K192774	BioCardia 8F Morph DNA Deflectable Guide Catheter	Biocardia, Inc.	DQY	Class II	2020-01-07
K192754	Avenger Radial Head System	In2bones USA, LLC	KWI	Class II	2020-01-07
K192715	CRF Radiofrequency Ablation System	Cambridge Interventional LLC	GEI	Class II	2020-01-07
K191870	VV330 Continuous ECG Platform, VivaLNK Adhesive Patch	Vivalnk, Inc.	DRG	Class II	2020-01-07
K190942	Disposable Powder Free Nitrile Examination Glove, Pink/Black Color	Ever Growth (Vietnam) Co., Ltd.	LZA	Class I	2020-01-07
K190651	ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter	ERBE Elektromedizin GmbH	GEH	Class II	2020-01-07
K193125	R2P Destination Slender Guiding Sheath	Terumo Medical Corp.	DYB	Class II	2020-01-06
K193102	MRIaudio PREM System with MRIview	Mriaudio, Inc.	LNH	Class II	2020-01-06
K192917	ViewPoint 6	GE Medical Systems Ultrasound and	LLZ	Class II	2020-01-06
K192903	RS85 Diagnostic Ultrasound System	Samsung Medison Co., Ltd.	IYN	Class II	2020-01-06
K192827	Quadra-P	Medacta International SA	LZO	Class II	2020-01-06
K192497	EVOL ha - D Lateral Interbody Fusion System	Cutting Edge Spine	MAX	Class II	2020-01-06
K192412	SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece	Dentalez, Inc.	EFB	Class I	2020-01-06
K191642	TK Sterile Piston Syringe without Needle	Anhui Tiankang Medical Technology Co., Ltd.	FMF	Class II	2020-01-06
K191123	Multi-unit Abutments	Medentika GmbH	NHA	Class II	2020-01-06