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 565 of 3529

510(k) clearances, page 565 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K171120	Senhance Surgical Robotic System	Asensus Surgical, Inc.	NAY	Class II	2017-10-13
K171015	Citryte	Di-Chem, Inc.	KPO	Class II	2017-10-13
K170241	GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose Monitoring System, GlucoDr.S NFC Blood Glucose Monitoring System	All Medicus Co., Ltd.	NBW	Class II	2017-10-13
K170233	Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter)	Zhanjiang Star Enterprise Co., Ltd.	EZD	Class II	2017-10-13
K170232	AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer	Boditech Med Inc.	JLW	Class II	2017-10-13
K170151	Electronic Blood Pressure Monitor	Shenzhen Pango Electronic Co., Ltd.	DXN	Class II	2017-10-13
K163696	SleepImage System	Mycardio, LLC dba Sleepimage.	MNR	Class II	2017-10-13
K163653	NOVOS-NAIL Limb Lengthening System (LLS)	Smith & Nephew, Inc.	HSB	Class II	2017-10-13
K163277	SuperNO2VA Device	Revolutionary Medical Devices, Inc.	BSJ	Class I	2017-10-13
K162362	PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator	Pms Tibbi Cihazlar Teknolojisi San ve Tic AS	FRG	Class II	2017-10-13
K172793	Skr 3000	Konica Minolta, Inc.	MQB	Class II	2017-10-12
K172414	JUD custom fit condom	Global Mailer Partners, LLC	HIS	Class II	2017-10-12
K172305	CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump	Datascope Corp.	DSP	Class II	2017-10-12
K171874	Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use With Chemotherapy Drugs (Dawn Blue)	Hartalega Sdn Bhd	LZA	Class I	2017-10-12
K171796	Vial Adapter 15mm	Medimop Medical Project, Ltd.	LHI	Class II	2017-10-12
K171782	Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy drugs	Blue Sail Medical Co.,Ltd	LZA	Class I	2017-10-12
K171497	Mikron Spinal Fixation System	Mikron Makina Sanayi Ticaret Co., Ltd.	MNI	Class II	2017-10-12
K171279	Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and Sterile Latex Surgical Powder Free Gloves	Top Glove Sdn. Bhd.	KGO	Class I	2017-10-12
K171169	Aquarius 8600 1417TG and Aquarius 8600 1717TG	Imaging Dynamics Company, Ltd.	MQB	Class II	2017-10-12
K170840	MAGNETOM Terra	Siemens Medical Solutions USA, Inc.	LNH	Class II	2017-10-12
K170154	Creavo Vitalscan Magnetocardiograph	Creavo Medical Technologies, Ltd.	DPS	Class II	2017-10-12
K170147	Lucica Glycated Albumin-L	Asahi Kasei Pharma Corporation	LCP	Class II	2017-10-12
K170146	Galaxy UNYCO System	Orthofix SRL	KTT	Class II	2017-10-12
K170085	SONON Ultrasound Imaging System, Model: 300L	Healcerion Co., Ltd	IYN	Class II	2017-10-12
K172742	AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)	AtriCure, Inc.	FZP	Class II	2017-10-11
K172123	NuVasive® Modulus XLIF Interbody System	Nu Vasive, Incorporated	MAX	Class II	2017-10-11
K172118	U by Kotex Click Unscented Menstrual Tampons	Kimberly-Clark Corporation	HEB	Class II	2017-10-11
K171984	Clickfine Pen Needle, Penfine Classic Pen Needle	Ypsomed AG	FMI	Class II	2017-10-11
K171765	Nihon Kohden CO2 Monitor	Nihon Kohden Corp.	CCK	Class II	2017-10-11
K162340	Stomach Tube	Well Lead Medical Co. Ltd	KNT	Class II	2017-10-11
K172739	higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing)	Higi SH LLC	DXN	Class II	2017-10-10
K172724	XIA® 4.5 Spinal System, Power Adaptor Instrument Accessory	Stryker Corp.	NKB	Class II	2017-10-10
K171593	InMode RF System	Inmode MD, Ltd.	GEI	Class II	2017-10-10
K171373	3M Bair Hugger Model 675 Total Temperature Management System	3M Company	DWJ	Class II	2017-10-10
K172682	Edge Digital Flat Panel X-ray Detector	Osko, Inc.	MQB	Class II	2017-10-06
K172681	Edge Air Digital Flat Panel X-ray Detector	Osko, Inc.	MQB	Class II	2017-10-06
K172672	Endoscopic Applicator, 41 cm	Micromedics, Inc. (D/B/A Nordson Medical)	GCJ	Class II	2017-10-06
K172413	Mt One	M&T SRL	GEX	Class II	2017-10-06
K172406	Ingenuity TF	Philips North America LLC	KPS	Class II	2017-10-06
K172399	MicroMatrix	ACell, Inc	KGN	Unclassified	2017-10-06
K172188	Aquilion Prime SP, TSX-303B/1, v8.4	Toshiba Medical Systems Coroporation	JAK	Class II	2017-10-06
K172097	Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves	ReNovo, Inc.	NLM	Class II	2017-10-06
K171801	IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable	Philips Medizin Systeme Boeblingen GmbH	MHX	Class II	2017-10-06
K171397	Sienna Ultimate Wireless Amplifier	EMS Handels Gesellschaft M.B.H.	GWL	Class II	2017-10-06
K170672	Tamper Evident Cap For use with ENFit Syringes	Intl. Medical Industries	PNR	Class II	2017-10-06
K170470	Digital Eye Anterior Camera	Medimaging Integrated Solution, Inc (Miis)	HJO	Class II	2017-10-06
K170394	Kisses Mini	Achimhai Medical Corporation	DZE	Class II	2017-10-06
K170319	Low Profile Non-Balloon Feeding Device	Applied Medical Technology Inc	KNT	Class II	2017-10-06
K170281	MSA100BT Peak Flow Meter	Beijing M&B Electronic Instruments Co., Ltd.	BZH	Class II	2017-10-06
K170089	U-Motion II Acetabular System— Additional sizes	United Orthopedic Corp.	LZO	Class II	2017-10-06