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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 866 of 3530

510(k) clearances, page 866 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K122052	Minifix Ball Minifix One	Bonafix Surgical and Dental Implants, LLC	DZE	Class II	2012-11-28
K121775	Enflow IV Fluid Warmer, Enflow Disposable Cartridge, Enflow Controller	Vital Signs, Inc., A GE Healthcare Company	LGZ	Class II	2012-11-28
K121475	Txcell Scanning Laser Delivery System	Iridex Corporation	GEX	Class II	2012-11-28
K123379	Abbott Architect Free T4	Abbott Medical	CEC	Class II	2012-11-27
K122725	Tanda Pearl, Ultrawyte, Pearl	Syneron Beauty	EEG	Class I	2012-11-27
K122561	Adaptain Fastwrap, Envelock, Graftain	Ceremed, Inc.	KHJ	Class II	2012-11-27
K121989	Optecure Bone Void Filler (0.5 Cc, 1Cc, 2Cc, 5Cc, 10Cc, and 20Cc), Optecure + Ccc Bone Void Filler (1Cc, 2Cc, 5Cc, 10Cc,	Exactech, Inc.	MQV	Class II	2012-11-27
K121763	Multicross Support Catheter	Roxwood Medical, Inc.	DQY	Class II	2012-11-27
K121346	Picosure Workstation	Cynosure, LLC	GEX	Class II	2012-11-27
K121093	D1 LED Curing Light, Spec 3, Dentronix LED 3000	Dxm Co., Ltd.	EBZ	Class II	2012-11-27
K120862	Water Bottle Cap Irrigaton System	Boston Scientific Corporation	FEQ	Class II	2012-11-27
K120787	Merete Locking Bone Plate System III	Merete GmbH	HRS	Class II	2012-11-27
K120651	Stabiliz Fixation System	Stabiliz Orthopaedics	HRS	Class II	2012-11-27
K121816	Sensus Electrode	Neurometrix, Inc.	GXY	Class II	2012-11-26
K121171	Curos Tip	Ivera Medical, Inc.	QBP	Class II	2012-11-26
K120904	Polaris Dial-a-Date Contact Lens Case	Reliance Design & Manufacture Corp.	LRX	Class II	2012-11-26
K120409	Piccolo Composite Plate System	CarboFix Orthopedics Inc.	HRS	Class II	2012-11-26
K112462	Kitazato Opu Needle	Kitazato Medical Co., Ltd.	MQE	Class II	2012-11-26
K121874	G7 Acetabular System	Biomet Manufacturing Corp	PBI	Class II	2012-11-23
K121363	Diowave Low Level Cold Laser System	Technological Medical Advancments, Inc. (Tma)	ILY	Class II	2012-11-23
K123015	.Decimal Photon Block	.Decimal, Inc.	IXI	Class II	2012-11-21
K122581	Modified Balloon Guide Catheter Model 90253, 90254	Concentric Medical, Inc.	DQY	Class II	2012-11-21
K122305	Corin Trinity-I Acetabular Shell	Corin USA	LZO	Class II	2012-11-21
K122154	Powerplay Muscle Massager	Fig, LLC	IRP	Class II	2012-11-21
K122110	Acon on Call Vivid Pal Blood Glucose Monitoring System	Acon Laboratories, Inc.	CGA	Class II	2012-11-21
K121963	Planmed Nuance Digiguide	Planmed Oy	MUE	Class II	2012-11-21
K121953	Hemasorb Apply	Orthocon, Inc.	MTJ	Unclassified	2012-11-21
K121811	Powder Free Sterile Latex Exam Radiation Attenuation Gloves	Shen Wei (USA), Inc.	LZC	Class I	2012-11-21
K121662	Vecttor Vt-200	Alan Neuromedical Technologies, LLC	LIH	Class II	2012-11-21
K121216	Str Graft	Soft Tissue Regeneration, Inc.	OWW	Class II	2012-11-21
K120326	Aqt90 Flex Ckmb Test Kit, Aqt90 Flex Lqc Multi-Check, Levels 1-3, Aqt90 Flex Ckmb Cal Cartridge	Radiometer Medical ApS	JHX	Class II	2012-11-21
K120217	Sonicstimu Combo Therapeutic Device	Shenzhen Dongdixin Technology Co., Ltd.	IMG	Class II	2012-11-21
K123409	Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design	Surgical Specialties Corp. dba Angiotech	GAM	Class II	2012-11-20
K123375	Syngo.via	Siemens Corp.	LLZ	Class II	2012-11-20
K123297	Compress Segmental Humeral Replacement System	Biomet Manufactuting Corp.	MBF	Class II	2012-11-20
K123229	Remote Presence System, Model Rp-Vita	Intouch Health, Inc.	DRG	Class II	2012-11-20
K123198	Liquichek Ethanol/ammonia Control Level 1 Model 271, Liquichek Ethanol/ammonia Control Level 2 Model 272, Liquichek Etha	Bio-Rad Laboratories Inc.	JJY	Class I	2012-11-20
K123039	Cdi Blood Parameter Monitoring System 500	Terumo Cardiovascular Systems Corporation	DRY	Class II	2012-11-20
K122931	S-Lok Pss System	Spinal USA	MNI	Class II	2012-11-20
K122772	Penumbra Ddc Catheters	Penumbra Inc.	DQY	Class II	2012-11-20
K122606	Pht-6500; Pht-60Cfo; Pax-I3d	Mtechgroup	OAS	Class II	2012-11-20
K122596	Arthroscopic Surgical Instruments - Interference Screw Systems	Smith & Nephew, Inc.	HWC	Class II	2012-11-20
K122573	Hi-Torque Command Guide Wire Family	Abbott Vascular	DQX	Class II	2012-11-20
K122488	Amigo Remote Catheter System & Accessories	Catheter Robotics, Inc.	DXX	Class II	2012-11-20
K122467	3M True Definition Scanner	3M Company	NOF	Class II	2012-11-20
K122454	Fujifilm Dual Energy Subtraction (Des) Software Option	FUJIFILM Healthcare Americas Corporation	KPR	Class II	2012-11-20
K122443	Ufit Ten-10	Biosign Technologies, Inc.	DXN	Class II	2012-11-20
K122229	Viceroy Spinal System	Torrey Spine	NKB	Class II	2012-11-20
K121977	Plasmajet Neutral Plasma Surgery System	Plasma Surgical Inc.	GEI	Class II	2012-11-20
K121865	Zoll Rescuenet 12-Lead	ZOLL Medical Corporation	MSX	Class II	2012-11-20