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 1371 of 3531

510(k) clearances, page 1371 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K042157	Daptomycin Antimicrobial Susceptibility Test Disc	Oxoid, Ltd.	JTN	Class II	2004-09-14
K042113	Zoe Fluid Status Monitor	Noninvasive Medical Technologies, Inc.	DSB	Class II	2004-09-14
K041982	Vitek 2 Gram Negative Ertapenem	bioMerieux, Inc.	LON	Class II	2004-09-14
K041964	Mediaid Reusable Finger Clip Spo2 Sensors and Disposable Non-Adhesive Sensors and Adhesive Spo2 Sensors	Mediaid, Inc.	DQA	Class II	2004-09-14
K041795	Modification to Optical Separator System	Applied Medical Resources Corp	GCJ	Class II	2004-09-14
K041771	Twin Star Compartment Syndrome Pressure Monitoring and Fluid Collection Catheter System	Twin Star Medical, Inc.	LXC	Unclassified	2004-09-14
K041528	Modification to Eptfe Graft	Vascutek, Ltd.	DSY	Class II	2004-09-14
K041522	Flexi-Stat Disposable Adhesive Spo2 Sensors	Elekon Industries U.S.A., Inc.	DQA	Class II	2004-09-14
K041442	Ep-4 Clinical Stimutator	Abbott Medical	JOQ	Class II	2004-09-14
K041269	Atrium Medical Corporation Icast Covered Stent	Atrium Medical Corporation	JCT	Class II	2004-09-14
K040479	Pediatric Energy Reducer, Models AED-10 and AED-20	Welch Allyn Inc	MKJ	Class III	2004-09-14
K040392	Transducers for Ultrasound and Tocodynamometer Fetal Monitoring	American I.V. Products, Inc.	HFM	Class II	2004-09-14
K032991	Light Age Epicare Alexandrite Laser, Models 501-1H, 501-Sp, 501-Lp and 501-Lpx	Light Age, Inc.	GEX	Class II	2004-09-14
K041941	Safe T Retractable Blood Collection Device	Safe T Medical Devices, Ltd.	FMI	Class II	2004-09-13
K041784	Raven Protest - Eo	Raven Biological Laboratories, Inc.	FRC	Class II	2004-09-13
K041694	Digital Flexible Thermometer, Basic Digital Thermometer, Ditital Pacifier Thermometer	Hangzhou Hua'an Medical & Health Instruments Co.	FLL	Class II	2004-09-13
K041692	Infrared Ear Thermometer, Et-100 Series	Hangzhou Hua'an Medical & Health Instruments Co.	FLL	Class II	2004-09-13
K041621	Liteport Lp100 Surgical Illuminator	Medical Vision Industries, Inc.	FTF	Class II	2004-09-13
K040143	Monorail	Nats Corp.	DZE	Class II	2004-09-13
K042294	Slumbergear(tm), Model Multiple (004, 005, 005, 007)	Suiter Enterprises, Inc.	BZD	Class II	2004-09-10
K042280	Fact Plus One-Step Pregnancy Test Kit	Unipath, Ltd.	LCX	Class II	2004-09-10
K042262	Integra Oxygen Concentrator, Model 6323A-Om-10	Sequal Technologies, Inc.	CAW	Class II	2004-09-10
K042225	Acmi Invisio Icn, Models Icn-0564 and Icn-0565	Acmi Corporation	FAJ	Class II	2004-09-10
K042202	Tempteller - High Speed Digital Thermometers, Models Dt-302, Dt-312, Dt-412, Dt-502	Oriental System Technology, Inc.	FLL	Class II	2004-09-10
K042026	Bard Ck Parastomal Hernia Patch, Models 0118001, 0118002, 0118003, 0118004	C.R. Bard Inc	FTL	Class II	2004-09-10
K041930	Varilite Laser System	Iridex Corporation	GEX	Class II	2004-09-10
K041906	Exactech 12/14 Total Hip System	Exactech, Inc.	LPH	Class II	2004-09-10
K041867	Hygia Health Services Reprocessed Oximax Sensors Model # Hhs-Max-a, Hhs-Max-Al, Hhs-Max-N	Hygia Health Services, Inc.	NLF	Class II	2004-09-10
K041811	Abbott Axsym Troponin-I Adv	Abbott Medical	MMI	Class II	2004-09-10
K041791	5.2F Dual Lumen Extended Length Catheter (Delc)	Chf Solutions, Inc.	NQJ	Class II	2004-09-10
K041578	Quickscreen, Models 9177X and 9178X	Phamatech Inc.	LCM	Unclassified	2004-09-10
K041381	Meropack Bioresorbable Nasal Packing and Sinus Stent	Medtronic Xomed, Inc.	LYA	Class I	2004-09-10
K041285	Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and Plasmacision Electrodes)	Gyrus ACMI, Inc.	GEI	Class II	2004-09-10
K040725	Bd Facscanto System	Becton Dickinson Immunocytometry Systems	GKZ	Class II	2004-09-10
K040491	Chin-Up Strip	Dale Miller, Inc. - the Chin-Up Company	LWF	Class I	2004-09-10
K040178	Pulseox 5500 Finger Device, Pulseox 7500 Wristwatch Device	S.P.O. Medical Equipment, Ltd.	DQA	Class II	2004-09-10
K040026	Bd Facs 7-Color Setup Beads	Becton Dickinson Immunocytometry Systems	GKZ	Class II	2004-09-10
K033341	Smith & Nephew Image Guided Surgical Instruments for Hip Applications	Smith & Nephew, Inc.	HAW	Class II	2004-09-10
K042313	Integradweb Mpr/mip	Dynamic Imaging, Inc.	LLZ	Class II	2004-09-09
K042311	Pacspartner	Medical Standard Co., Ltd.	LLZ	Class II	2004-09-09
K042213	Pre-Powdered Non-Sterile Vinyl Examination Gloves	Shandong Perfect Plastic Co., Ltd.	LYZ	Class I	2004-09-09
K042151	Acon Spectrum Hcg Midstream Pregnancy Test	Acon Laboratories, Inc.	LCX	Class II	2004-09-09
K042139	Visulas Yag III	Carl Zeiss Meditec Inc	GEX	Class II	2004-09-09
K041924	Hausted Powertran Series Stretcher	STERIS Corporation	INK	Class II	2004-09-09
K041764	The Vitros 5,1 Fs Chemistry System	Ortho-Clinical Diagnostics, Inc.	LCP	Class II	2004-09-09
K041743	Acon Tri-Fect Drug Screen Test Device	Acon Laboratories, Inc.	DKZ	Class II	2004-09-09
K041468	Premicath, 1261.205	Vygon Corp.	LJS	Class II	2004-09-09
K041361	Randox Tri Level Cardiac Control	Randox Laboratories, Limited	JJY	Class I	2004-09-09
K041215	Cranial Helmet	Otto Bock Healthcare LP	MVA	Class II	2004-09-09
K041186	Caddy	Afikim Electric Vehicles	ITI	Class II	2004-09-09