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 2026-10-12, 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 249 of 3528

510(k) clearances, page 249 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K223184	Phantom Metatarsal Shortening System	Paragon 28	HWC	Class II	2022-12-16
K223153	Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology	Medtronic Sofamor Danek USA Inc	MAX	Class II	2022-12-16
K222820	BRM TOOL Screws, BIOPLAN Subtalar Implant	BRM Extremities SRL	HWC	Class II	2022-12-16
K222798	Rejoni Intrauterine Catheter	Rejoni, Inc	LKF	Class II	2022-12-16
K222608	Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS	Tuttnauer Ltd.	FLE	Class II	2022-12-16
K222502	Klick (Variants: Power, Race, Monster)	Klaxon-Mobility GmbH	ITI	Class II	2022-12-16
K222275	Saige-Density	Deephealth	QIH	Class II	2022-12-16
K220928	Overjet Calculus Assist	Overjet	MYN	Class II	2022-12-16
K220554	Caduceus S	Taiwan Main Orthopaedic Biotechnology Co., Ltd	SBF	Class II	2022-12-16
K220281	multiFiltratePRO System	Fresenius Medical Care Renal Therapies Group, LLC	KDI	Class II	2022-12-16
K220052	Copan FecalSwab Collection, Transport and Preservation System	Copan Italia	JSM	Class I	2022-12-16
K220036	Wellead Ureteral Catheter	Well Lead Medical Co. Ltd	KOD	Class II	2022-12-16
K220010	Daylily Single Use Sterile Embryo Transfer Catheter	Shanghai Horizon Medical Technology Co., Ltd.	MQF	Class II	2022-12-16
K213984	Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307)	Shenzhen Zhengkang Technology Co., Ltd.	DQA	Class II	2022-12-16
K213601	Surgical Mask	Wuhan Zonsen Medical Products Co., Ltd	FXX	Class II	2022-12-16
K213110	AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor	Auxein medical Private Limited	MBI	Class II	2022-12-16
K212559	CardioPhase® hsCRP	Siemens Healthcare Diagnostics Products Limited	NQD	Class II	2022-12-16
DEN220012	Tornier Pyrocarbon Humeral Head	Tornier S.A.S.	QKW	Class II	2022-12-16
K223472	TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013)	Spectranetics Corp.	DRE	Class II	2022-12-15
K222892	Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs	Grand Work Plastic Products Co., Ltd.	LZA	Class I	2022-12-15
K221555	Dozee VS	Turtle Shell Technologies Private Limited	BZQ	Class II	2022-12-15
K221453	S.I.N. Dental Implant System	S.I.N. Implant System Ltda	DZE	Class II	2022-12-15
K221267	VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor	Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.	MWI	Class II	2022-12-15
K221102	LOTUS Series 4 Enhanced Shears, LOTUS Series 5	SRA Developments Ltd	LFL	Unclassified	2022-12-15
K220883	Small Field Applicator	Hitachi High-Tech Corp., Kashiwanoha	LHN	Class II	2022-12-15
K220873	Perceptive electric dental motor and control unit	Lares Research	EIA	Class I	2022-12-15
K220591	Proxima	Dynasthetics	NFB	Class II	2022-12-15
K220520	PM Excellence SEQUR 100 Surgical Face Mask	Pm Excellence, LLC	FXX	Class II	2022-12-15
K214086	Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty	GENOSS Co., Ltd.	ELW	Class II	2022-12-15
K222623	Digital Crown	Sprintray Inc.	EBF	Class II	2022-12-14
K222533	Target Tetra Detachable Coils	Stryker Corp.	HCG	Class II	2022-12-14
K222527	Nitrile Patient Examination Glove	Pingan Medical Products Co., Ltd.	LZA	Class I	2022-12-14
K221910	QRS Dental Implants System	Qrs Medical, Ltd.	DZE	Class II	2022-12-14
K221891	UNO Negative Pressure Wound Therapy System	Genadyne Biotechnologies, Inc.	OMP	Class II	2022-12-14
K221800	Infrared Thermometer (Model: Y20001, Y20002)	Zhangzhou Easepal Medical Science and Technology Co.,Ltd.	FLL	Class II	2022-12-14
K221245	PTA Balloon Dilatation Catheter	Kossel MedTech (Suzhou) Co., Ltd.	LIT	Class II	2022-12-14
K220971	QuikClot Control+ Hemostatic Dressing	Z-Medica, LLC	POD	Class II	2022-12-14
K220079	Magicore Narrow System	Innobiosurg Co., Ltd.	DZE	Class II	2022-12-14
K213722	ICE Ceramics, ICE Stains, Fresco	Zirkonzahn SRL	EIH	Class II	2022-12-14
K223433	Quantra QPlus System	Hemosonics, LLC	QFR	Class II	2022-12-13
K222770	Conductive Gel	Top-rank Health Care Co.,Ltd.	GYB	Class II	2022-12-13
K222651	Surgical Face Mask	Xiantao Sanda Industrial Co., Ltd	FXX	Class II	2022-12-13
K221342	REDEMPTION Beaming System	Vilex LLC	HWC	Class II	2022-12-13
K221318	Hvt 2.0	Vapotherm Inc.	QAV	Class II	2022-12-13
K220046	Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11	Shenzhen Superbio Technology Co., Ltd.	DJG	Class II	2022-12-13
K214004	CCBIO ASCPO Needle	Cc Biotechnology Corporation	FMI	Class II	2022-12-13
K213105	Epilaser Absolute	Epilady 2000, LLC	GEX	Class II	2022-12-13
K212071	Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx	Cefaly Technology	PCC	Class II	2022-12-13
K223510	Matrix HA Fusion Porous Cervical IBF System	Innovasis, Inc	ODP	Class II	2022-12-12
K223190	Hive™ Standalone Cervical System	NanoHive Medical LLC	OVE	Class II	2022-12-12