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 364 of 3528

510(k) clearances, page 364 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K202616	ClearCap Distal Attachment	Finemedix	OCX	Class II	2021-02-19
K202432	MiniLoad Syringe	Ocuject, LLC	FMF	Class II	2021-02-19
K202380	Born PT-LIF Cage HA	Spineworxx AG	MAX	Class II	2021-02-19
K202346	SPiN Vision Video Bronchoscope System	Veran Medical Technologies, Inc.	EOQ	Class II	2021-02-19
K202303	CORE E3 Suction/irrigator	ConMed Corporation	GCJ	Class II	2021-02-19
K202232	Comprehensive Vault Reconstruction System	Biomet Manufacturing Corp	PHX	Class II	2021-02-19
K202212	TruPlan	Circle Cardiovascular Imaging Inc	LLZ	Class II	2021-02-19
K202188	Safety Blood Collection Sets for Single Use	Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.	JKA	Class II	2021-02-19
K201860	Elos Accurate Hybrid Base	Elos MedTech Pinol a/S	NHA	Class II	2021-02-19
K201680	NuFACE Mini Plus	Carole Cole Company	NFO	Class II	2021-02-19
K201425	Disposable Intraoperative Probe (DIOP8)	Huntleigh Healthcare Ltd.	ITX	Class II	2021-02-19
K201379	Artemis Proximal Femoral Nail System	Glw, Inc.	HSB	Class II	2021-02-19
K201274	Ultrasonic Osteotomy Surgical System	Smtp Technology Co., Ltd.	JDX	Class II	2021-02-19
K201182	iMask Disposable Surgical Face Mask	Pac-Dent Inc.	FXX	Class II	2021-02-19
K200589	MyPAO Planning Report	Medacta International SA	LLZ	Class II	2021-02-19
K200527	pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR water-based, pjur med Moisturising glide,pjur med NATURAL glide, We-Vibe Lube made by pjur	pjur group Luxembourg S.A.	NUC	Class II	2021-02-19
K210329	Green X 18(Model : PHT-75CHS)	Vatech Co., Ltd.	OAS	Class II	2021-02-18
K210137	EsoCheck Cell Collection Device	Lucid Diagnostics, Inc.	EOX	Class II	2021-02-18
K210136	PhantomMSK Hip	Orthogrid Systems, Inc	LLZ	Class II	2021-02-18
K203426	Surgical Face Mask (non-sterile)	Nantong Taiweishi Medical Technology Co., Ltd.	FXX	Class II	2021-02-18
K202687	Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60	Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.	FLL	Class II	2021-02-18
K202574	LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus	Diasorin Inc.	LSR	Class II	2021-02-18
K202573	LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus	Diasorin Inc.	LSR	Class II	2021-02-18
K202498	4CIS SARA Spine System, 4CIS VERTU Spine System	Solco Biomedical Company India Private Limited	NKB	Class II	2021-02-18
K201863	Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape	SOMATEX Medical Technologies GmbH	NEU	Class II	2021-02-18
K201720	LiPPS Analyzer, LiPPS Wire Pressure Guide Wire	Beijing Bywave Sensing Medical Technology Co., Ltd.	DQX	Class II	2021-02-18
K201412	BEGO SEMADOS Tr 58350; BEGO SEMADOS RS/RSX-Line Tray Plus, BEGO Semados Tr 58349; BEGO Semados Tr 58348, BEGO Semados DSTr 58356; Drill Stop Tray Plus (RS/RSX-Line), BEGO SEMADOS PKTr 58357; Prosthetic Kit	Bego Implant Systems GmbH & Co. KG	KCT	Class II	2021-02-18
K201408	Demetra Analytics Toolkit	Barco N.V.	PSN	Class II	2021-02-18
K201378	3D Accuitomo 150N	J. Morita USA, Inc.	OAS	Class II	2021-02-18
K193330	Clue Birth Control	Biowink GmbH	PYT	Class II	2021-02-18
K210252	iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizing (PS) Knee Replacement System	ConforMIS, Inc.	JWH	Class II	2021-02-17
K210132	s-Clean SQ-SL Implant System Regular	Dentis Co.,Ltd	DZE	Class II	2021-02-17
K203399	Fitbone(r) Taa	Wittenstein Intens GmbH	HSB	Class II	2021-02-17
K203307	Viola	Vascular Graft Solutions	DXC	Class II	2021-02-17
K202401	Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein	Eco Medi Glove Sdn Bhd	KGO	Class I	2021-02-17
K202338	SpaceFlex Shoulder	G21, S.r.l.	MBB	Class II	2021-02-17
K210444	EZ-Injec LDV Sterile Safety Needle	Poonglim Pharmatech, Inc.	QNS	Class II	2021-02-16
K210443	PLPT LDV (Low Dead Volume) Sterile Syringe	Poonglim Pharmatech, Inc.	QNQ	Class II	2021-02-16
K210234	cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System	Roche Molecular Systems Inc	OCC	Class II	2021-02-16
K210114	Rebar Micro Catheter	Micro Therapeuatics, Inc. D/B/A Ev3 Neurovascular	KRA	Class II	2021-02-16
K210035	ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System	Aegis Spine, Inc.	OUR	Class II	2021-02-16
K203670	Extra Large Check-Flo Introducer	Cook Incorporated	DYB	Class II	2021-02-16
K203419	Relivion	NEUROLIEF Inc.	PCC	Class II	2021-02-16
K203312	Vitrea Software Package, VSTP-001A	Canon Medical Systems Corporation	LLZ	Class II	2021-02-16
K201732	Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On	Dukal LLC	FXX	Class II	2021-02-16
K201391	Easytech® Anatomical Shoulder System	Fx Shoulder USA, Inc.	PKC	Class II	2021-02-16
K200626	VesselIQ Xpress	GE Medical Systems SCS	JAK	Class II	2021-02-16
K200160	740 SafeSAT	Zoe Medical, Inc.	MWI	Class II	2021-02-15
K203766	4D Integrated Treatment Console	Varian Medical Systems, Inc.	MUJ	Class II	2021-02-12
K203740	JuggerKnot Soft Anchor	Riverpoint Medical, LLC	MBI	Class II	2021-02-12