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 306 of 3528

510(k) clearances, page 306 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K213317	ShinEvac Smoke Evacuation Pencil	Shining World Health Care Co., Ltd.	GEI	Class II	2022-01-28
K213142	Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate Simulated Gastric Acid Solution	Shen Wei (USA), Inc.	LZA	Class I	2022-01-28
K213093	STEP-1 PumEtch	Rounding Third LLC	KLE	Class II	2022-01-28
K213082	Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311	Guangzhou Berrcom Medical Device Co., Ltd	FLL	Class II	2022-01-28
K212943	SyntheCel Dura Repair	Synthes (USA) Products LLC	GXQ	Class II	2022-01-28
K212648	VITROS Immunodiagnostic Products CK-MB Reagent Pack	Ortho-Clinical Diagnostics, Inc.	JHX	Class II	2022-01-28
K212598	iHealth infrared Ear thermometer PT5	Andon Health Co., Ltd	FLL	Class II	2022-01-28
K212533	BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants	Straumann USA, LLC	DZE	Class II	2022-01-28
K212341	Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U,Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U	Spectrum Medical Inc	DTZ	Class II	2022-01-28
K212120	Surgical Masks	Hubei Xinxin Non-woven Co., Ltd	FXX	Class II	2022-01-28
K211096	Optiflow Oxygen Kit	Fisher & Paykel Healthcare, Inc.	BTT	Class II	2022-01-28
K203395	Platform treatment system	Shanghai Apolo Medical Technology Co.,Ltd.	GEX	Class II	2022-01-28
K203260	syngo.CT Brain Hemorrhage	Siemens Medical Solutions USA, Inc.	QAS	Class II	2022-01-28
K213771	Merlin Aspiration System	Mivi Neurovascular	DXE	Class II	2022-01-27
K213493	Fortilink with TiPlus Technology	Paradigm Spine GmbH	ODP	Class II	2022-01-27
K213489	Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate	Wishbone Medical, Inc.	HRS	Class II	2022-01-27
K213475	Elevo Snoring Intervention Set	Zelegent, Inc.	LRK	Class II	2022-01-27
K213211	Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System	Carolina Liquid Chemistries	DIO	Class II	2022-01-27
K212373	Sim&Size	Sim&cure	PZO	Class II	2022-01-27
K212312	RA-T59 Wrist blood pressure monitor	Lotusnine Medical Limited	DXN	Class II	2022-01-27
K211941	9Line	Energetic Designs, Inc.	DSA	Class II	2022-01-27
K211589	VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger	Remington Medical	DPW	Class II	2022-01-27
K211436	Intermittent Catheter (Not Finalized)	Hollister Incorporated	GBM	Class II	2022-01-27
K211210	Sterile Auto-Disable Syringes with/without Needle for Single Use	Azur Medical Company, Inc.	FMF	Class II	2022-01-27
K210360	Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models)	Osteonic Co., Ltd.	GWO	Class II	2022-01-27
K203774	SmartAdjust technology	Insulet Corporation	QJI	Class II	2022-01-27
K203772	Omnipod 5 SmartBolus Calculator	Insulet Corporation	QRX	Class II	2022-01-27
K203768	Omnipod 5 ACE Pump (Pod)	Insulet Corporation	QFG	Class II	2022-01-27
K213692	SmoothSkin Pure Mini	Cyden Limited	OHT	Class II	2022-01-26
K213591	ANTHEM® Fracture System	Globus Medical, Inc.	HRS	Class II	2022-01-26
K212938	Vitalograph Model 6000 Alpha	Vitalograph Ireland Ltd.	BZG	Class II	2022-01-26
K212868	JFil Ureteral Stents, JFil Ureteral Stents ECO KIT	Rocamed Sam	FAD	Class II	2022-01-26
K212771	LightStim Elipsa	LED Intellectual Properties LLC	OHS	Class II	2022-01-26
K212610	Surgical Face Mask	Foshan Nanhai Plus Medical Co Ltd	FXX	Class II	2022-01-26
K211219	LASSOSTAR NAV Circular Mapping Catheter	Biosense Webster Inc	DRF	Class II	2022-01-26
K210101	American-Made Surgical Mask	Armbrust Inc.	FXX	Class II	2022-01-26
K202914	SternaFuse Fixation System	Fusion Innovations	HRS	Class II	2022-01-26
K213347	ADI Medical Surgical Face Mask	Asia Dynamics Inc., D/B/A Adi Medical	FXX	Class II	2022-01-25
K212173	HDH Treatment Planning System	CDB Corporation	PNN	Class II	2022-01-25
K211355	iCare HOME2	Icare Finland Oy	HKY	Class II	2022-01-25
K201323	INNO SLA Submerged Implant System	Cowellmedi Co., Ltd.	NHA	Class II	2022-01-25
K213780	DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1	Canon, Inc.	MQB	Class II	2022-01-24
K213639	Revaclear 500, Revaclear 400, Revaclear 300	Baxter Healthcare Corporation	KDI	Class II	2022-01-24
K212333	Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5	Canon Medical Systems Corporation	IYN	Class II	2022-01-24
K211482	Disposable Syringe with Needle	Shandong Qinkai Medical Industry Co., Ltd.	FMF	Class II	2022-01-24
K213970	D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply	Danameco Medical Joint Stock Corporation	FXX	Class II	2022-01-23
K212111	Myflon Surgical Mask Level 3	Feliks Plastik Laminasyon ve Ambalaj Malzemeleri Sanayi	FXX	Class II	2022-01-23
K210810	Steiking Packaging for Medical Devices	Wipak Oy	FRG	Class II	2022-01-23
K210463	Thermoplastic Elastomer (TPE) Hybrid Examination Glove	Xuzhou Full Sun Medical Products Ltd.	LZA	Class I	2022-01-23
K214030	Universal DR 1748	Konica Minolta, Inc.	MQB	Class II	2022-01-21