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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 1392 of 3531

510(k) clearances, page 1392 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K040475	Micromax Suture Anchor	Zimmer GmbH	HWC	Class II	2004-05-21
K040153	I-Tec Portable Dental Operatory	Indigenous Peoples Technology and Education Center	EBW	Class I	2004-05-21
K033983	Vitalab Iron Reagent	Clinical Data, Inc.	JIY	Class I	2004-05-21
K033627	Q.steps Biometer G Blood Glucose Monitoring System	Biomedix Wai	CGA	Class II	2004-05-21
K033623	Celsius Control System	Innercool Therapies	NCX	Class II	2004-05-21
K033474	Zoll AED Plus	ZOLL Medical Corporation	MKJ	Class III	2004-05-21
K032755	Model 509M Pulse Oximeter, Model 509M	Respironics Novametrix, LLC.	DQA	Class II	2004-05-21
DEN040003	Glucatell	Associates of Cape Cod, Inc.	NQZ	Class II	2004-05-21
K041273	One-Step Pregnancy Test	W.H.P.M., Inc.	LCX	Class II	2004-05-20
K041230	Clinical Laboratory Analyzing System	HemoCue AB	LFR	Class II	2004-05-20
K041164	L-TENS	FUJI Dynamics Limited	GZJ	Class II	2004-05-20
K040859	Heraceram Press	Kulzer GmbH	EIH	Class II	2004-05-20
K040829	Gelweave Ante-Flo with Collar and Gelweave 4 Branch Plexus with Collar	Vascutek, Ltd.	DSY	Class II	2004-05-20
K040677	Combi Self Propelled Shower Commode	Kjaerulff Rehabilitation A/S	IOR	Class I	2004-05-20
K040575	Pharmatech Menopause Check, Models 9111 and 9112	Phamatech Inc.	CGJ	Class I	2004-05-20
K040524	Porta Solder 1090 W	Wieland Dental + Technik GmbH & Co. KG	EJT	Class II	2004-05-20
K040520	Slip Urology Introducer Sheath	Percutaneous Systems, Inc.	KNY	Class II	2004-05-20
K040519	Slip Urology Catheter	Percutaneous Systems, Inc.	EZD	Class II	2004-05-20
K040442	Protex Stabilization System	Globus Medical, Inc.	MNH	Class II	2004-05-20
K040324	Wilson-Cook Double Lumen Biliary Cytology Brush	Wilson-Cook Medical Inc.	FDX	Class II	2004-05-20
K033899	Lifestream Plus Cholesterol Monitor, Modification to Resolution Cholesterol Monitor	Lifestream Technologies, Inc.	NFX	Class I	2004-05-20
K021845	Stardust II, Model 1011176	Respironics, Inc.	MNR	Class II	2004-05-20
K041006	Tandem-Cath Hemodialysis Catheter, Model 10 Fr	Kendall	MSD	Class II	2004-05-19
K040951	Sr Adoro	Ivoclar Vivadent, Inc.	EBG	Class II	2004-05-19
K040822	Liquichek Torch Plus Igm Control	Bio-Rad Laboratories Inc.	JJY	Class I	2004-05-19
K040636	Cadd Administration Set with Flow Stop, Medication Cassette Reservoir with Flow Stop and Extension Set	Abbott Medical	FPA	Class II	2004-05-19
K040603	Paradigm Link Blood Glucose Meter	Becton Dickinson & Co	NBW	Class II	2004-05-19
K040457	Nomad from Dynamis Mobility Ltd.	Dynamis Mobility, Ltd.	ITI	Class II	2004-05-19
K040445	Acon Ppx One Step Propoxyphene Test Strip and Acon Ppx Step Propoxyphene Test Device	Acon Laboratories, Inc.	JXN	Class II	2004-05-19
K040433	Sinon	Wavelight Laser Technologie AG	GEX	Class II	2004-05-19
K040371	A & D Medical Ua-767Bt Digital Blood Pressure Monitor	A and D Engineering, Inc.	DXN	Class II	2004-05-19
K040152	Bone Cement for Cranioplasty	Cardinalhealth	GXP	Class II	2004-05-19
K033885	Bmbp Enzyme Immunoassay, Cat #0610, 0611 (500, 5000 Test Kit)	Lin-Zhi International Inc	DIS	Class II	2004-05-19
K033688	Micro H2 Breath Monitoring Device with Hydra Software Utility	Micro Direct, Inc.	NRH	Class I	2004-05-19
K033142	Powered Wheelchair	Nats Corp.	ITI	Class II	2004-05-19
K032575	First Sign Drug of Abuse Screening Test	W.H.P.M., Inc.	DKZ	Class II	2004-05-19
K041154	S-Scort...jr Quickdraw, Model 2400	Sscor	BTA	Class II	2004-05-18
K040736	Vaxcel Plus Chronic Dialysis Catheter	Boston Scientific Corporation	MSD	Class II	2004-05-18
K040477	Monoderm	Surgical Specialties Corp	GAM	Class II	2004-05-18
K040013	Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray Ancillary Kit	Possis Medical, Inc.	QEZ	Class II	2004-05-18
K032517	Medsafe Clicksafe Safety Antistick Syringe with Hypodermic Needle	Medsafe Technologies, LLC	MEG	Class II	2004-05-18
K031357	Guarddog Occlusion System, Occlusion Guidewire, 300 Cm, Guarddog Occlusion System Occlusion Guidewire, 200 Cm	Possis Medical, Inc.	MJN	Class II	2004-05-18
K041228	Mytech/happy Life Blood Pressure Monitor, Model Hpl-200	Mytech Technology Co., Ltd.	DXN	Class II	2004-05-17
K041176	Uretex to Trans-Obturator Urethral Support System	Sofradim Production	OTN	Class II	2004-05-17
K041166	Siemens Enhanced Imaging System	Siemens Medical Solutions USA, Inc.	KPS	Class II	2004-05-17
K041058	Misonix Inc. Lysonix 2000/3000 Ultrasonic Surgical Aspirator Systems	Misonix, LLC	QPB	Class II	2004-05-17
K040927	Linical Protein 1 Calibration Verifiers Levels a - E for Olympus Au Analyzers	Cliniqa Corporation	JJX	Class I	2004-05-17
K040918	Wako Lipid Control, Level 1 and Level 2	FUJIFILM Healthcare Americas Corporation	JJX	Class I	2004-05-17
K040870	Shimadzu Image Amplifier, Model Ia-16L/hs	Shimadzu Corp.	JAA	Class II	2004-05-17
K040825	Lake Region Hydrophilic Guidewire	Lake Region Mfg., Inc.	DQX	Class II	2004-05-17