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 847 of 3530

510(k) clearances, page 847 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K123351	Affinity Af100 Arterial Filter with Carmeda Bioactive Surface	Medtronic Perfusion Systems	DTM	Class II	2013-03-19
K123330	Iogyn Endoscope	Iogyn, Inc.	HIH	Class II	2013-03-19
K123208	Digital Retinal Camera	Canon Inc. -Medical Equipment Group	HKI	Class II	2013-03-19
K122940	Advance Micro 14 Ultra Low Profile Balloon Dilatation Catheter Model Pta3	Cook Inc.	DQY	Class II	2013-03-19
K122522	Dentoetch Quickbond Bond Activator	Itena Clinical	KLE	Class II	2013-03-19
K122220	Eni-Eye Sh Soft K Semi Scleral (Efrofilcon a) Soft (Hydrophilic) Keratoconus and Irregular Cor Eni-Eye Sh Soft K Toric S	Soflex Limited	LPL	Class II	2013-03-19
K123890	Acumed Cannulated Screw System	Acumed LLC	HWC	Class II	2013-03-18
K123767	Lanx Fusion System- Sa	Lanx, Inc.	OVD	Class II	2013-03-18
K123628	Sterile Latex Surgical Glove	Lucenxia Prescience AG	KGO	Class I	2013-03-18
K123546	3M Attest(tm) Auto-Reader	3M Company	FRC	Class II	2013-03-18
K123485	Juggerknotless Soft Anchors, Juggerknotless M Soft Anchors, Juggerknotless Soft Anchors with Needles, Juggerknotless Sof	Biomet Sports Medicine	MBI	Class II	2013-03-18
K123219	Urgoclean Absorbent Wound Dressing	Laboratoires Urgo	FRO	Unclassified	2013-03-18
K122702	Biofriend Biomask N95 Surgical Respirator	Filligent Limited	ONT	Class II	2013-03-18
K122059	All-Suture Anchor Twist Drill for All-Suture Anchors Inline Drill Guide for All-Suture Anchors	Smith & Nephew, Inc.	MBI	Class II	2013-03-18
K130236	Range + Qualicheck Level 1, Range + Qualicheck Level 2, Range + Qualicheck Level 3	Radiometer Medical ApS	JJS	Class I	2013-03-15
K130210	Medela Thopaz	Medela AG	BTA	Class II	2013-03-15
K130142	Flixene Ifg Vascular Graft	Atrium Medical Corporation	DSY	Class II	2013-03-15
K130138	Super Sani-Cloth/ Accu-Chek Inform II System	Roche Diagnostics GmbH	NBW	Class II	2013-03-15
K123298	Fem-Felx, Fex-Flex II Femoral Access Cannula with Duraflo Coating	Edwards Lifesciences LLC	DWF	Class II	2013-03-15
K123225	Bonos R 1X20, Bonos R 2X20, Bonos R 1X40, Bonos R 2X40, Bonos R 1X60	Aap Biomaterials GmbH & Co. KG	LOD	Class II	2013-03-15
K123108	Tvc Imaging System Model Nirs-Mc7-70	Nipro Vascular Innovations Americas, Inc.	OGZ	Class II	2013-03-15
K123070	Galileos Family	Sirona Dental Systems GmbH	OAS	Class II	2013-03-15
K122918	Rayscan a-Expert	Ray Co., Ltd.	MUH	Class II	2013-03-15
K122415	X-Fix Dynamic External Distractor	Arex USA	HTY	Class II	2013-03-15
K121593	3M Attest (Tm) Super Radid Readout Steam Challenge Pack 3M Attest(tm) Super Rapid 5 Steam-Plus Challenge Pack	3M Company	FRC	Class II	2013-03-15
K121520	Ultrasonic Nebulizer (Mesh Type)	K-Jump Health Co., Ltd.	CAF	Class II	2013-03-15
K130435	Versaport V2 Bladeless Optical Trocar	Covidien, Formerly US Surgical A Divison of Tyco H	GCJ	Class II	2013-03-14
K130351	Nanotack Suture Anchor 1.4Mm with Flex Inserter	Pivot Medical	MBI	Class II	2013-03-14
K130124	Catalyst II and III	Cardiva Medical, Inc.	DXC	Class II	2013-03-14
K123948	China Nails and Accessories	Smith & Nephew, Inc.	JDS	Class II	2013-03-14
K123933	Microscan Dried Gram-Positive Mic/combo Panels - Ceftaroline	Siemens Healthcare Diagnostics Inc.	LTT	Class II	2013-03-14
K123929	Begopal+	Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & Co	EJH	Class II	2013-03-14
K123783	Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol Implants	Globus Medical, Inc.	KWP	Class II	2013-03-14
K123782	Paragon Hip System	Global Manufacturing Technology	LZO	Class II	2013-03-14
K123557	Easycare Online	ResMed Corp	MNS	Class II	2013-03-14
K123186	Resolutionmd Mobile 3.1 Model Rmd-Mob-31	Calgary Scientific, Inc.	LLZ	Class II	2013-03-14
K123161	Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original, Smartguard Elite	Smartguard, Inc.	MQC	Unclassified	2013-03-14
K122907	Fastep at-Home Pregnancy, Hcg, Over the Counter	Polymed Therapeutics, Inc.	LCX	Class II	2013-03-14
K122534	Immulite 1000 Third Generation Psa Calibration Verification Material	Siemens Healthcare Diagnostics Inc.	JJX	Class I	2013-03-14
K121933	Nexsite Hd Hemodialysis Catheter for Long Term Use (28Cm) Nexsite Hd Hemodialysis Catheter for Long Term Use (24Cm)	Marvao Medical Devices Ltd.	MSD	Class II	2013-03-14
K121747	Facefit and Facefit Ported Non-Invasive Ventilation Masks	Intersurgical Incorporated	BZD	Class II	2013-03-14
K121622	Nidek Rs-3000	Nidek Co., Ltd.	OBO	Class II	2013-03-14
K120014	Sta- Coag Control (N+abn) Plus	Diagnostica Stago, Inc.	GGN	Class II	2013-03-14
K130520	Capiox Fx15 and Fx25 Hollow Fiber Oxygenator/reservoir	Ashitaka Factory of Terumo Corp.	DTZ	Class II	2013-03-13
K130493	Capiox Rx05 Hollow Fiber Oxygenator/reservoir	Terumo Corp.	DTZ	Class II	2013-03-13
K130359	Capiox Sx18 Hollow Fiber Oxygenator with Detachable Hardshell Reservoir, Capiox Sx25 Hollow Fiber Oxgenator with Detacha	Terumo Cardiovascular Systems Corporation	DTZ	Class II	2013-03-13
K130333	Capix Rx Hollow Fiber Oxygenator With/without Hardshell Reservoir	Terumo Cardiovascular Systems Corporation	DTZ	Class II	2013-03-13
K130280	Capiox Fx Hollow Fiber Oxygenator W/ Reservoir	Terumo Corp.	DTZ	Class II	2013-03-13
K130251	Esophagus Bougie Set	Varian Medical Systems, Inc.	JAQ	Class II	2013-03-13
K130234	Nuvon Vitals Charting System	Nuvon, Inc.	MWI	Class II	2013-03-13