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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 567 of 3529

510(k) clearances, page 567 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K172309	Endoscopic Ultrasound Aspiration Needle	Micro-Tech (Nanjing) Co., Ltd.	ODG	Class II	2017-09-29
K172080	Photoelectric Therapy System	Xstrahl Limited	JAD	Class II	2017-09-29
K172065	Scarlet Ac-T	Spineart SA	ODP	Class II	2017-09-29
K171795	Thommen Implant System	Thommen Medical AG	DZE	Class II	2017-09-29
K171792	Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit	Alere Scarborough, Inc.	OCC	Class II	2017-09-29
K171685	Med4 Elite	Cool Systems, Inc. (dba Game Ready)	IRP	Class II	2017-09-29
K171463	ASPIRE Bellus II	FUJIFILM Healthcare Americas Corporation	LLZ	Class II	2017-09-29
K171440	Berkeley VC-10 Vacuum Curettage System	Gyrus ACMI, Inc.	HHI	Class II	2017-09-29
K171408	Carbon Monoxide Breath Sensor System (COBSS)	Carrot Sense, Inc.	CCJ	Class II	2017-09-29
K171309	BR-FHUS Navigation 1.0	Taihao Medical, Inc.	IYO	Class II	2017-09-29
K170505	SecurePortIV Catheter Securement Adhesive	Adhezion Biomedical, LLC	NZP	Class II	2017-09-29
K170166	CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture	CPT Sutures Co., Ltd.	GAM	Class II	2017-09-29
K170119	Calix Lumbar Spinal Implant System	Xtant Medical Holdings, Inc.	MAX	Class II	2017-09-29
K163407	Confirm Rx Insertable Cardiac Monitor (ICM) System	Abbott Medical	MXC	Class II	2017-09-29
K163326	SmartEP	Intelligent Hearing Systems Corp.	GWJ	Class II	2017-09-29
K172659	MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable Polyglactin 910 Surgical Sutures, MITSU FST - Absorbable Polyglactin 910 Surgical Suture, FILAXYN - Absorbable Polydioxanone Surgical (PDS), FILAPRON - Absorbable poly(glycolide-co-caprolactone) Surgical Suture	M/s. Meril Endo Surgery Private Limited.	GAM	Class II	2017-09-28
K172612	FiberTak DX	Arthex, Inc.	MBI	Class II	2017-09-28
K172595	CUSA Excel+ Ultrasonic Surgical Aspirator System	Integra LifeSciences Corporation	LFL	Unclassified	2017-09-28
K171965	Resection Electrodes with HF cable	Olympus Winter & Ibe GmbH	FAS	Class II	2017-09-28
K171922	Anatotemp Anatomic Dental Implant Healing Abutment	Buckeye Medical Technologies LLC	NHA	Class II	2017-09-28
K171894	NuVasive® Precept™ Spinal System	Nu Vasive, Incorporated	NKB	Class II	2017-09-28
K171728	MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm	Sterngold Dental LLC	DZE	Class II	2017-09-28
K171633	NuVasive TLX Interbody System	Nu Vasive, Incorporated	MAX	Class II	2017-09-28
K171212	AirFit N20	ResMed Corp	BZD	Class II	2017-09-28
K170802	TRAUMACEM™ V+ Injectable Bone Cement	Synthes (USA) Products LLC	LOD	Class II	2017-09-28
K170498	Gems Oocyte Retrieval Buffer ORB-20, ORB-50	GENEA BIOMEDX Pty Ltd.	MQL	Class II	2017-09-28
K170262	Digital Thermometer	K-Jump Health Co., Ltd.	FLL	Class II	2017-09-28
K170020	Peel-Away Introducer Set	Cook Incorporated	DYB	Class II	2017-09-28
K163455	SurgiCube	Surgicube International B.V.	ORC	Class II	2017-09-28
K163442	Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft)	Modern Medical Equipment Manufacturing Ltd.	GEI	Class II	2017-09-28
K161434	Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)	Li-Tek Electronics Technologies	OLP	Class II	2017-09-28
K172275	Vitality® Spinal Fixation System, Vitality®+ Power Instrument System	Highridge Medical, LLC	NKB	Class II	2017-09-27
K172109	Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256 µg/mL	Liofilchem S.r.l.	JWY	Class II	2017-09-27
K171941	FreeStyle Precision Neo Blood Glucose Test Strips	Abbott Medical	NBW	Class II	2017-09-27
K171936	Peerbridge Cor(TM) System	Peerbridge Health, Inc.	DSH	Class II	2017-09-27
K171661	Scopis Extended Instrument Set EM	Scopis GmbH	PGW	Class II	2017-09-27
K171215	QiF Blood and Fluid Warmer	Quality in Flow Ltd.	LGZ	Class II	2017-09-27
K171211	OIC External Fixation System	The Orthopaedic Implant Company	KTT	Class II	2017-09-27
K170810	Cryofos	Cryofos Medical GmbH	GEH	Class II	2017-09-27
K170482	Spider Frame External Fixation System	Tasarimmed Tibbi Mamuller Sanayi ve Ticaret A.S	KTT	Class II	2017-09-27
K170183	Cetus system, Cetus probe	A.R.C. Laser GmbH	HQE	Class II	2017-09-27
K172581	CareView 1800Cw X-ray Flat Panel Detectors	Careray Digital Medical System Co., Ltd.	MQB	Class II	2017-09-26
K172101	ROMEO® 2 Posterior Osteosynthesis System	Spineart SA	NKB	Class II	2017-09-26
K172015	Powder Free Nitrile Examination Gloves, Blue (Colored)	Careglove Global Sdn Bhd	LZA	Class I	2017-09-26
K171992	SculpSure	Cynosure, LLC	PKT	Class II	2017-09-26
K171963	Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes	Hologic, Inc.	OCC	Class II	2017-09-26
K171107	CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System	Medtronic Sofamor Danek USA Inc	MAX	Class II	2017-09-26
K170816	Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM	Brainlab, Inc.	LLZ	Class II	2017-09-26
K170162	Vesco Medical Nasoenteric Feeding Tubes	Vesco Medical LLC	PIF	Class II	2017-09-26
K172628	PRECICE System	NuVasive Specialized Orthopedics, Inc.	HSB	Class II	2017-09-25