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 796 of 3530

510(k) clearances, page 796 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K131168	Immunalysis Oxycodone Enzyme Immunoassay	Immunalysis Corporation	DJG	Class II	2014-01-17
K130614	Bone Fragment and Fixation Plates, Screws and Washers	Laura Cattabriga	HRS	Class II	2014-01-17
K123517	Glucomentor Blood Glucose Monitoring System, Glucomentor Multi Blood Glucose Monitoring System	SD Biosensor, Inc.	NBW	Class II	2014-01-17
DEN130018	Cytoscan(r) Dx	Affymetrix Inc	PFX	Class II	2014-01-17
K133856	Powerglide Midline Catheter	C.R. Bard Inc	FOZ	Class II	2014-01-16
K133727	Q-Fix Suture Anchor, 1.8Mm; Q-Fix Suture Anchor, 2.8Mm; Drill, Drill Guide and Obturator, 1.8Mm & 2.8Mm, Firstpass Sutu	ArthroCare Corporation	MBI	Class II	2014-01-16
K133698	Synapse System	Synthes (USA) Products LLC	KWP	Class II	2014-01-16
K133379	Hem-7311	Omron Healthcare Co., Ltd.	DXN	Class II	2014-01-16
K133250	Starlight	Orthomerica Products, Inc.	OAN	Class II	2014-01-16
K133164	Dynesys Top-Loading Spinal System	Zimmer Spine, Inc.	NQP	Class II	2014-01-16
K132894	Optio-C Anterior Cervical System	Zimmer Spine, Inc.	OVE	Class II	2014-01-16
K132528	E-Picco Continuous Cardiac Output Module and Accessories	GE Healthcare Finland Oy	DXG	Class II	2014-01-16
K132363	Dolphix External Fixation System	Citieffe Inc.	KTT	Class II	2014-01-16
K131857	Q-Switched Nd:yag Laser	Beijing Honkon Technologies Co., Ltd.	GEX	Class II	2014-01-16
K131799	Quicknit	Microcopy, Div. of Neo-Flo, Inc.	MVL	Unclassified	2014-01-16
K131151	Endocenter	Satelec-Acteon Group	ELC	Class II	2014-01-16
K130945	Calprest	Eurospital S.p.A.	NXO	Class II	2014-01-16
K130732	Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)	Aide Plastic Co., Ltd.	LYZ	Class I	2014-01-16
K133473	Iluminage Skin Smoothing Laser	Cynosure, LLC	OHS	Class II	2014-01-15
K133120	Computed Radiography Scanner	3Disc Americas	MQB	Class II	2014-01-15
K133106	Computed Radiography Scanner	3Disc Americas	MQB	Class II	2014-01-15
K132844	Straumann Cares Bone Level Screw Retained Bars, Straumann Cares Bone Level Screw Retained Bridges	Straumann USA, LLC	NHA	Class II	2014-01-15
K131864	U2 Tibial Baseplate- Cma Type, Tibial Insert and Augment	United Orthopedic Corp.	JWH	Class II	2014-01-15
K131113	Biophotas Celluma	Biophotas, Inc.	ILY	Class II	2014-01-15
K131110	One Step Single/multi-Drug Test Cup; One Step Single Single/multi-Drug Test Dipcard	Co-Innovation Biotech Co.,Ltd.	DKZ	Class II	2014-01-15
K133499	Suzhou Beinuo Surgical Staplers - Circular Staplers for Single Use, Hemorrhoidal Circular Staplers for Single Use, Linea	Suzhou Beinuo Medical Equipment Co., Ltd.	GDW	Class II	2014-01-14
K133369	Tiger Spine System	Corelink, LLC	NKB	Class II	2014-01-14
K132984	Sr Vivodent S, Sr Orthotyp S, Sr Ortholingual S	Ivoclar Vivadent, Inc.	ELM	Class II	2014-01-14
K132739	Immulite 2000 Afp, Br-Ma, and Om-Ma Calibration Verification Material	Siemens Healthcare Diagnostics Inc.	JJX	Class I	2014-01-14
K130737	Synthetic Absorbable Suture	Foosin Medical Supplies Inc., Ltd.	GAM	Class II	2014-01-14
K130735	Synthetic Absorbable Suture	Foosin Medical Supplies Inc., Ltd.	GAM	Class II	2014-01-14
K130692	M2 Wrist 2 MRI System	Aspect Imaging Ltd	LNH	Class II	2014-01-14
K130036	Cosense Co Monitor	Capnia Inc	CCJ	Class II	2014-01-14
K123758	Tasmin R	Signus Medizintechnik GmbH	MQP	Class II	2014-01-14
K133684	Ultrablox	Bloxr Corporation	PDK	Class II	2014-01-13
K133407	Gem Premier 4000	Instrumentation Laboratory Co.	CHL	Class II	2014-01-13
K133066	Spineselect Polyscrew Pedicle Screw System	Spineselect, LLC	NKB	Class II	2014-01-13
K133063	Santis Pedicle Screw System	Lanterna Medical Technologies	NKB	Class II	2014-01-13
K133021	Mixing Syringe System	Zimmer Knee Creations	FMF	Class II	2014-01-13
K132669	Proxifast Absorbable Staple	Surgimatix, Inc.	GDW	Class II	2014-01-13
K132641	Modified Trevo Provue Retriever	Concentric Medical, Inc.	NRY	Class II	2014-01-13
K132606	S9 Cronulla for Her	ResMed Corp	BZD	Class II	2014-01-13
K131410	Co2/o2 Nasal Cannula (with 4 (10Cm) O2 and CO2 Tube), Co2/o2 Nasal Cannula (with 8 (240Cm) O2 and 4 (10Cm) CO2 Tube),	Southmedic Inc.	CCK	Class II	2014-01-13
K130828	K Series CPAP Systems	Curative Medical, Inc.	BZD	Class II	2014-01-13
K130674	Entuit Thrive Lp Balloon Retention Gastrostomy Feeding Tube	Xeridiem Medical Devices	KNT	Class II	2014-01-13
K130552	CT Pulmonary Analysis	Qi Imaging, LLC	JAK	Class II	2014-01-13
K133604	Anspach Eg1 High Speed System, G1 Attachments	The Anspach Effort, Inc.	HBC	Class II	2014-01-10
K133310	Axium Detachable Coil System	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular	HCG	Class II	2014-01-10
K133302	Flexmap 3D	Luminex Corporation	NSU	Class II	2014-01-10
K133191	Probeam Proton Therapy System	Varian Medical Systems, Inc.	LHN	Class II	2014-01-10