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 907 of 3530

510(k) clearances, page 907 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K111480	Maxiflex - Semi Flex Scope, 25 to 65 Cm	Technology Delivery Systems, Inc.	FGB	Class II	2012-04-04
K111274	Jetprep Flushing Device Ol-103037 / Ol-133037 / Ol-168037 / Pe-105038 / Pe-150038 / Pe-170038 / Fu-169038	Jetprep, Ltd.	OCX	Class II	2012-04-04
K120694	Encore 26 Advantage Kit	Boston Scientific Corporation	MAV	Class II	2012-04-03
K120670	Hamilton-T1	Hamilton Medical AG	CBK	Class II	2012-04-03
K120238	Rtvue Xr Oct	Optovue Inc.	HLI	Class II	2012-04-03
K120204	Reprocessed Femoral Compression Device	Sterilmed Inc	NMF	Class II	2012-04-03
K120069	Medline Stopcock and Manifold	MEDLINE INDUSTRIES, LP - Northfield	DTL	Class II	2012-04-03
K120065	Plaxtron Suction Unit, Model 88Aa51/88aa61 Series	Plaxtron Industrial (M) Sdn. Bhd.	JCX	Class II	2012-04-03
K113759	Avaira (Enfilcon a) Contact Lens	CooperVision, Inc.	LPL	Class II	2012-04-03
K113371	Staphylococcus Quickfish Bc	Advandx, Inc.	NXX	Class I	2012-04-03
K113361	Securis Spinal Fixation	Cumtom Spine	NKB	Class II	2012-04-03
K113144	Pagewriter Tc 20, 30, 50, 70	Philips North America LLC	DPS	Class II	2012-04-03
K113115	Epicare Yag	Light Age, Inc.	GEX	Class II	2012-04-03
K111636	Rehab Tnt, Rehab Ram, Rehab Mac, Rehab Kidster, Bariatric Rehab Tnt and Rehab Ram	GUNNELL, Inc.	IOR	Class I	2012-04-03
K120802	Ortholoc(tm) 3Di Locking Screws Ortholoc(tm) Bone Screws	Wrightmedicaltechnologyinc	HRS	Class II	2012-04-02
K120735	Pathassit Light Seeker	Entellus Medical, Inc.	LRC	Class I	2012-04-02
K120696	Tiger Spine System	Corelink, LLC	MNI	Class II	2012-04-02
K120433	Clear + Brilliant Laser System	Solta Medical, Inc.	ONG	Class II	2012-04-02
K120330	Penumbra Coil System/penumbra Coil 400	Penumbra Inc.	HCG	Class II	2012-04-02
K120190	Disposable Powder Free Vinyl Exam Glove, Blue Color	Rich Mountain Medical Products, Inc.	LYZ	Class I	2012-04-02
K113829	Zimmer Patient Specific Instrument System Zimmer Patient Specific Instruments Zimmer Patient Specific Instruments Planne	Materialise N.V.	JWH	Class II	2012-04-02
K112982	Anatomic Ankle Arthrodesis Interlocking Nail(a3 Interlocking Nail )	Small Bone Innovations, Inc.	HSB	Class II	2012-04-02
K112426	Xian Friendship Disposable Nerve Stimulator Probes	Xian Friendship Medical Electronics Co., Ltd.	ETN	Class II	2012-04-02
K112247	A Baer with Abaer I/o Function	Natus Medical Incorporated	EWO	Class II	2012-04-02
K111695	Hybrid Graft	Cook Biotech, Inc.	FTL	Class II	2012-04-02
K120799	Arisure Neutral Valve	Yukon Medical, LLC	FPA	Class II	2012-03-30
K120563	Keypath Mrsa/mssa Blood Culture Test-Bt	Microphage, Inc.	OUS	Class I	2012-03-30
K120379	Panavia Sa Cement Automix Value Pack (Universal (A2), White) Panavia Sa Cement Automix (Universal (A2), White) Panavia S	Kuraray Medical, Inc.	EMA	Class II	2012-03-30
K120378	Panavia Sa Cement Handmix Value Pack (Universal (A2), White) Panavia Sa Cement Handmix (Universal (A2), White) Panavia S	Kuraray Medical, Inc.	EMA	Class II	2012-03-30
K120273	Kittycat Catheter, Kittycat 2 Catheter	Avinger, Inc.	PDU	Class II	2012-03-30
K120221	Ge Echopac	GE Healthcare	LLZ	Class II	2012-03-30
K120213	Etch-Rite Supreme	Pulpdent Corporation	KLE	Class II	2012-03-30
K120145	Simple T Nasal Mask	Respironics, Inc.	BZD	Class II	2012-03-30
K113431	Ceramic Products Made in Yttria-Stabilized Zirconia	Bettini S.p.A.	EIH	Class II	2012-03-30
K113168	Dailies Total Dalies Total for Astigmatism Dailies Total Multifocal Dailies Total Multifocal Toric	Alcon Laboratories	LPL	Class II	2012-03-30
K112452	Angiodynamics Soft-Vu Angiographic Catheters	Boston Scientific Corporation	DQO	Class II	2012-03-30
K112351	Ultra Beauty	Johari Digital Healthcare, Ltd.	NFO	Class II	2012-03-30
K112119	Cunther Tulip(r) Vena Cava Filter Set for Femoral Approach, Cook Celect(r) Vena Cava Filter for Femoral Approach	William Cook Europe ApS	DTK	Class II	2012-03-30
K111664	Diazyme Cystatin C Poc Test Kit	Diazyme Laboratories, Inc.	NDY	Class II	2012-03-30
K111549	Attune Sleep Apnea System	Apnicure, Inc.	OZR	Class II	2012-03-30
K111058	Uretron Model Urt	Med-Sonics Corp.	FFK	Class II	2012-03-30
K110019	Respiratory Humidifer	Fisher & Paykel Healthcare, Inc.	BTT	Class II	2012-03-30
K103834	Bioplex 2200 Apls Igg and Iga Kit and Calibrator and Control Sets	Bio-Rad Laboratories Inc.	MID	Class II	2012-03-30
DEN110002	System 1E Process Biological Monitoring Kit	STERIS Corporation	OVY	Class II	2012-03-30
K120893	Imager II Angiographic Catheters	Boston Scientific Corporation	DQO	Class II	2012-03-29
K120738	Flash Pta Balloon Dilatation Catheter-4.0X14mmx135cm	Verge Medical Inc.	LIT	Class II	2012-03-29
K120627	Toshiba 1.5T Qd Head Coil	Quality Electrodynamics	MOS	Class II	2012-03-29
K120616	Spacelabs Healthcare Qube Compact Monitor (91390	GE Healthcare	MHX	Class II	2012-03-29
K120578	Accolade II Hip Stem	Howmedica Osteonics Corp	JDI	Class II	2012-03-29
K120568	Freestyle Insulinx Blood Glucose Monitoring System	Abbott Medical	NBW	Class II	2012-03-29