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 299 of 3528

510(k) clearances, page 299 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K212330	Yadu Medical Face Mask (Level 1)	Henan Yadu Industrial Co.,Ltd	FXX	Class II	2022-03-14
K211420	Stasis Gel	Belport Company, Inc., Gingi-Pak	MVL	Unclassified	2022-03-14
K211324	2.4mm Distal Radius System	Auxein medical Private Limited	HRS	Class II	2022-03-14
K203744	Arterys MICA	Arterys Inc.	QIH	Class II	2022-03-14
K203738	Qitexio	Medex	FMF	Class II	2022-03-14
K213806	Disposable Medical Face Mask	Xiantao Zhibo Nonwoven Products Co.,Ltd	FXX	Class II	2022-03-12
K220425	MAGNETOM Vida, MAGNETOM Sola	Siemens Medical Solutions USA, Inc.	LNH	Class II	2022-03-11
K220422	Dental sensors NanoPix1, NanoPix2	Iray Technology Taicang, Ltd.	MUH	Class II	2022-03-11
K220395	EndoGator Endoscopy Irrigation Tubing	STERIS Corporation	FEQ	Class II	2022-03-11
K220315	MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty	Orthocon, Inc.	MTJ	Unclassified	2022-03-11
K213957	Demetra Dermatoscope BDEM-01	Barco N.V.	PSN	Class II	2022-03-11
K213869	EmbryoSlide+ ic8 dish	Vitrolife Inc.	MQK	Class II	2022-03-11
K213836	Intracept Intraosseous Nerve Ablation System	Relievant Medsystems	GXI	Class II	2022-03-11
K213827	TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst)	Smith & Nephew, Inc.	KWS	Class II	2022-03-11
K213725	CardIQ Suite	GE Medical Systems SCS	JAK	Class II	2022-03-11
K213712	Pectus Support Bar System	Biomet Microfixation	HRS	Class II	2022-03-11
K213687	32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch	NeoCoil, LLC	MOS	Class II	2022-03-11
K213658	Deka Smartperio	El.en. Electronic Engineering SpA	NVK	Class II	2022-03-11
K213615	Shoulder Innovations Total Shoulder System	SHOULDER INNOVATIONS, Inc	PKC	Class II	2022-03-11
K213534	PHantom Trilogy	Resurgeonz, LLC	OLI	Class II	2022-03-11
K213354	Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection Cables, Unify Wireless FootSwitch, Unify Cart	ConMed Corporation	GEI	Class II	2022-03-11
K213005	Apollo Ankle Fracture Plating System	Glw Medical, Inc.	HRS	Class II	2022-03-11
K212920	Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use	ShanDong WeiGao Group Medical Polymer Co., Ltd	FMF	Class II	2022-03-11
K212628	DESS Dental Smart Solutions	Terrats Medical, S.L.	NHA	Class II	2022-03-11
K212040	Ri.hip Modeler	Blue Belt Technologies, Inc.	LLZ	Class II	2022-03-11
K211887	Personal Kinetigraph (PKG) System Gen 2 Plus	GKC Manufacturing Pty Ltd	GYD	Class II	2022-03-11
K211880	Minuteman G5 MIS Fusion Plate	Spinal Simplicity, LLC	PEK	Class II	2022-03-11
K202075	Dental Electric Motor	Foshan CICADA Dental Instrument Co., Ltd.	EBW	Class I	2022-03-11
K201351	Maxima Surgical Gown	Elevate Textiles	FYA	Class II	2022-03-11
K201229	Intai Anatomic Locking Plate and Screw System	Intai Technology Corp.	HRS	Class II	2022-03-11
K220361	Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide	STERIS Corporation	NZA	Class II	2022-03-10
K220133	Sterilization Wraps	Weihai Hongyu Nonwoven Fabric Products Co.,Ltd	FRG	Class II	2022-03-10
K214071	Hexa-Temp	Spident Co., Ltd.	EBG	Class II	2022-03-10
K213910	Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy Drugs	Changzhou Universal Medical Equipment Co., Ltd.	LZC	Class I	2022-03-10
K213751	NextAR™ TKA Platform My Knee PPS	Medacta International SA	SBF	Class II	2022-03-10
K213566	ClearRead Xray Pneumothorax	Riverain Technologies	QFM	Class II	2022-03-10
K213486	GLP systems Track	Abbott Medical	JGS	Class II	2022-03-10
K213373	Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate	Smart Glove Corporation Sdn. Bhd.	LZA	Class I	2022-03-10
K213038	Infrared Forehead Thermometer, model: HS-9802D	Jiaxing Shangjia Intelligence Technology Co., Ltd.	FLL	Class II	2022-03-10
K212965	Smile-100 System	Niramai Health Analytix Private Limited	LHQ	Class I	2022-03-10
K212755	SIGNUS SACRONAIL® Transsacral Stabilization System	Signus Medizintechnik GmbH	HWC	Class II	2022-03-10
K212165	Reprocessed Carto Vizigo Bi-Directional Guiding Sheath	Innovative Health, LLC.	PNE	Class II	2022-03-10
K212148	Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs	Ansell Healthcare Products LLC	LZA	Class I	2022-03-10
K211911	Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets	MEDLINE INDUSTRIES, LP - Northfield	LJE	Unclassified	2022-03-10
K210367	D-Laser Blue, D-Laser 16	Guilin Woodpecker Medical Instrument Co., Ltd	NVK	Class II	2022-03-10
K210341	One Step Pregnancy Test	SPD Swiss Precision Diagnostics GmbH	LCX	Class II	2022-03-10
K220376	Acetabular Dome Hole Plug	Howmedica Osteonics Corp., dba Stryker Orthopaedics	LPH	Class II	2022-03-09
K220340	Amplatzer Steerable Delivery Sheath	Abbott Medical	DQY	Class II	2022-03-09
K220096	Genesys Spine 3DP Lumbar Interbody System	Genesys Spine	MAX	Class II	2022-03-09
K220069	4K UHD LCD Monitor OEV321UH	Olympus Medical Systems Corp.	GCJ	Class II	2022-03-09