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 331 of 3528

510(k) clearances, page 331 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K212081	3M(TM) Comply(TM) Hydrogen Peroxide Indicator Tape 1228	3M Company	JOJ	Class II	2021-09-05
K211736	Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W)	Shenzhen Osto Technology Company Limited	NUH	Class II	2021-09-05
K212476	KARL STORZ Flexible HD Cysto-Urethroscope System	Karl Storz Endoscopy-America, Inc.	FAJ	Class II	2021-09-03
K212421	Adas 3D	ADAS3D Medical S.L	LLZ	Class II	2021-09-03
K211762	Altor Safety 4-Ply Surgical Mask (Model:62232)	Altor Safety	FXX	Class II	2021-09-03
K211637	Aroma Grand	Daeju Meditech Engineering Co., Ltd.	GEX	Class II	2021-09-03
K211583	Infrared Thermometer, Model: HW-1	Dongguan Simzo Electronic Technology Co., Ltd.	FLL	Class II	2021-09-03
K211200	WoundExpress	Huntleigh Healthcare Ltd.	JOW	Class II	2021-09-03
K210940	LuxaPrint Ortho Plus	DMG Digital Enterprises SE	MQC	Unclassified	2021-09-03
K210861	ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)	Stryker Corp.	KWS	Class II	2021-09-03
K210470	C-CURVE Interbody Fusion Device	Medicrea International	OVE	Class II	2021-09-03
K210342	BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor	STERIS Corporation	ODC	Class II	2021-09-03
K210133	Current Health Monitoring System Gen 2 (G2)	Current Health Inc	MSX	Class II	2021-09-03
K203536	Male Latex Condom	Global Protection Corp.	HIS	Class II	2021-09-03
K202786	Dental Low-speed Handpieces and Accessories	Microp Technology (Taiwan), Inc.	EFB	Class I	2021-09-03
K202689	Dentilube Spray	Oxy2plus, LLC	LFD	Unclassified	2021-09-03
K201305	Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain	Atrium Medical Corporation	CAC	Class II	2021-09-03
K212494	Lung Image Analysis	PULMONX, Corp.	JAK	Class II	2021-09-02
K212491	Air Relax Pro Model AR-4.0	Diode Art Engineering Doing Business AS Air Relax	IRP	Class II	2021-09-02
K211881	AI Segmentation	Varian Medical Systems, Inc.	MUJ	Class II	2021-09-02
K211778	Nitrile Examination Gloves, Green/ Blue/ Black Color	Zhenjiang Suhui Latex Products Co., Ltd.	LZA	Class I	2021-09-02
K211201	MagnetOs Easypack Putty	Kuros Biosciences BV	MQV	Class II	2021-09-02
K211074	Univers Revers Modular Glenoid System, Standard Augment Baseplates	Arthrex GmbH	PHX	Class II	2021-09-02
K210868	Nitrile Examination Gloves Powder Free (Blue)	Great Eco Glove Sdn. Bhd.	LZA	Class I	2021-09-02
K203722	RayPilot System	Micropos Medical AB	IYE	Class II	2021-09-02
K201612	Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5	Viramal Limited	NUC	Class II	2021-09-02
K201445	MultiCath, AcQRate Dx Fixed Curve Catheter	BIOTRONIK AG	DRF	Class II	2021-09-02
K212139	Admiral ACP System	SeaSpine Orthopedics Corporation	KWQ	Class II	2021-09-01
K211972	Omeza Collagen Matrix	Omeza, LLC	FRO	Unclassified	2021-09-01
K211823	Bonine Acupressure Bands	Wellspring Pharmaceutical Corporation	MVV	Unclassified	2021-09-01
K211673	Disposable Medical Nitrile Gloves	Changzhou Yihua Sanitation Material Co., Ltd.	LZA	Class I	2021-09-01
K211536	Welspun Health Surgical Mask	Welspun India Limited	FXX	Class II	2021-09-01
K211367	Evo sEEG System	Neuroone Medical Technologies Corp.	GZL	Class II	2021-09-01
K211174	IPL Hair Removal	Shenzhen Qiaochengli Technology Co., Ltd	OHT	Class II	2021-09-01
K210951	Leonardo Mini Blue	Ceramoptec GmbH	GEX	Class II	2021-09-01
K210901	Elecsys Vitamin D total III	Roche Diagnostics GmbH	MRG	Class II	2021-09-01
K210254	MeMed BV	MeMed Diagnostics Ltd	QPS	Class II	2021-09-01
K210032	Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless)	Leadtek Research, Inc.	DQA	Class II	2021-09-01
K203625	Numen Coil Embolization System; NumenFR Detachment System	MicroPort Neurotech (Shanghai) Co., Ltd.	HCG	Class II	2021-09-01
K203014	EndoLIF Delta-Cage and DoubleWedge-Cage	Joimax GmbH	MAX	Class II	2021-09-01
K202395	Sp-1000, Sp-2000	Daesung Maref Co.,Ltd	IRP	Class II	2021-09-01
K202204	Tracheal Stent System	Micro-Tech (Nanjing) Co., Ltd.	JCT	Class II	2021-09-01
K201258	EASYMAX Tag Self-Monitoring Blood Glucose System	Eps Bio Technology Corp.	NBW	Class II	2021-09-01
K212383	EndoNaut	Therenva SAS	OWB	Class II	2021-08-31
K212145	DR 800 with DSA, DR 800	Agfa N.V.	JAA	Class II	2021-08-31
K212083	Tactoset Injectable Bone Substitute	Anika Therapeutics, Inc.	MQV	Class II	2021-08-31
K211704	CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer System, FORZA PEEK Spacer System, FORZA PTC Spacer System, FORZA Ti Spacer System, FORZA XP Expandable Spacer System, Lonestar Cervical Standalone System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, PILLAR SA PTC Spacer System, SKYHAWK Lateral Interbody Fusion System	Orthofix SRL	ODP	Class II	2021-08-31
K211449	Triton™ Sacroiliac Joint Fixation System	Choice Spine LLC	OUR	Class II	2021-08-31
K210957	Kubec Xpert 80 Radiography System	Kub Technologies, Inc.	MWP	Class II	2021-08-31
K210956	Kubtec Mozart (XPERT42)	Kub Technologies, Inc.	MWP	Class II	2021-08-31