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 1844 of 3531

510(k) clearances, page 1844 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K972488	Ksea Hydromat 263110-20 Pressure Chambers and Accessories	Karl Storz Endoscopy-America, Inc.	HET	Class II	1998-01-22
K972451	Coregistration Function	Nomos Corp.	IYE	Class II	1998-01-22
K972022	Zak-2000	Cardio Systems, Inc.	FNM	Class II	1998-01-22
K971901	Radius Low Profile Gastrostomy Tube Kit	Radius Intl., Inc.	KNT	Class II	1998-01-22
K971851	Interpleural Anesthesia Catheter	Axiom Medical, Inc.	BSO	Class II	1998-01-22
K974312	Reusable Biopsy Forceps Oval Cup, Reusable Biosy Forceps Oval Cup W/needle, Reusable Biopsy Forceps Serrated Cup, Reusar	TeleMed Systems	KNW	Class II	1998-01-21
K974187	Stealthstation System	Surgical Navigation Technologies, Inc.	HAW	Class II	1998-01-21
K974107	Kodak Digital Science Quality Control Workstation (Qcw)	Eastman Kodak Company	LMD	Class I	1998-01-21
K974056	0.9.% Sodium Chloride Inhalation Solution, Usp	Holopack International, LP	CAF	Class II	1998-01-21
K974030	Carpal Engaging Wrist Fusion Plate	Terray Corp.	HRS	Class II	1998-01-21
K974028	Stargate Falloposcopy Catheter, Trifurcated Irrigation Tubing	Conceptus, Inc.	MKO	Class II	1998-01-21
K973788	Microvasive Lipthotripsy Probes	Boston Scientific Corporation	FFK	Class II	1998-01-21
K973624	Nurse's Aid Patient Rotation System	Air Med Assist Products	IOQ	Class II	1998-01-21
K973396	Quest Pet Imaging System	Ugm Medical Systems, Inc.	KPS	Class II	1998-01-21
K972643	Depuy Amk 3 Peg Patella	Depuy, Inc.	JWH	Class II	1998-01-21
K974719	Phacopak	Paradigm Medical Industries, Inc.	HQC	Class II	1998-01-20
K974567	Hewlett-Packard M2605a Viridia Wave Viewer	Hewlett-Packard Co.	MSX	Class II	1998-01-20
K974501	Digital Tinnitus Masking System	Petroff Audio Technologies	KLW	Class II	1998-01-20
K974281	Alcon Contact Lens Case	Alcon Laboratories	LRX	Class II	1998-01-20
K974243	Keratome System	Insight Technologies Instruments, LLC	HMY	Class I	1998-01-20
K974242	Argosy Programmable Onque	Argosy Electronics	ESD	Class I	1998-01-20
K974102	Miltra Imaging Inc., Image Vault	Mitra Imaging, Inc.	LMD	Class I	1998-01-20
K974086	Kodak Digital Science Cardiac Viewer	Eastman Kodak Company	LLZ	Class II	1998-01-20
K974077	Versaview Panoramic-Cephalometric Dental X-Ray Sys.	J. Morita USA, Inc.	EHD	Class II	1998-01-20
K974018	Wilson-Cook 10 Shot Multi-Band Ligator	Wilson-Cook Medical Inc.	FHN	Class II	1998-01-20
K972614	Twister Oxygen Concentrator Model 600, Twister Oxygen Concentrator W/opi Model 605	Healthdyne Technologies, Inc.	CAW	Class II	1998-01-20
K972385	Fenestrated Flexible D.i.c. Tracheostomy Tube Cuffed	Smiths Industries Medical Systems, Inc.	JOH	Class II	1998-01-20
K972034	Medpor Ocular Conformer	Porex Surgical, Inc.	HQN	Class II	1998-01-20
K974818	Abl555 Blood Gas, Electrolyte & Metabolite System	Radiometer America, Inc	MMI	Class II	1998-01-16
K974768	Pdi Sterile Lubricating Jelly	Nice-Pak Products, LLC	KMJ	Class I	1998-01-16
K974633	Scantech Laser Scanner	Phantom Technologies, Inc.	GEX	Class II	1998-01-16
K974460	Lite Touch Erbium Laser Treatment System	Lorad Corp.	GEX	Class II	1998-01-16
K974346	Starlight Pulsed Diode Array Laser System	Star Medical Technologies, Inc.	GEX	Class II	1998-01-16
K974061	Rechargeable Battery Part Number Gl825-200	Alexander Mfg. Co.	DXN	Class II	1998-01-16
K974017	Timesh System	Sofamor Danek USA,Inc.	HRS	Class II	1998-01-16
K974010	Advantage EMG System, Model #A100	Advantage Medical Division of Cme Telemetrix	IKN	Class II	1998-01-16
K973991	Metron Qa-510 Spo2 Analyzer	Metron U.S., Inc.	DQA	Class II	1998-01-16
K973984	Rac 2A Module Housing	Marquette Medical Systems, Inc.	CCK	Class II	1998-01-16
K973830	Powder Free Patient Examination Glove Safe Glove	Safe Glove, Ltd.	LYY	Class I	1998-01-16
K973633	Atrion Medical Products Lacrimal Intubation Set	Atrion Medical Products, Inc.	OKS	Unclassified	1998-01-16
K973309	Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw	Vilex, Inc.	HWC	Class II	1998-01-16
K973046	Spacemaker Surgical Balloon Dissector, Spacemaker II Surgical Balloon Dissector, Saphtrak	General Surgical Innovations	GCJ	Class II	1998-01-16
K972967	Osteonics Scorpio Total Knee Universal Dome Patellar Component;osteonics Scorpio Total Knee Recessed Patellar Component	Osteonics Corp.	JWH	Class II	1998-01-16
K972857	Servotronic Ec100 System	Medicon, E.G.	HBC	Class II	1998-01-16
K972562	Bipolar Electrosurgical Pencil, Straight and Angled	Electroscope, Inc.	GEI	Class II	1998-01-16
K972332	Aesculap Craniofix Titanium Clamp System	Aesculap Inc	GXN	Class II	1998-01-16
K972242	Reveal Insertable Loop Recorder (Ilr) System	Medtronic, Inc.	MXC	Class II	1998-01-16
K972176	Home Care Bead Bed	KCI USA, Inc.	INX	Class II	1998-01-16
K971813	Embla	Ferguson Medical	OLV	Class II	1998-01-16
K970572	Dual Integrator Dental Implant Accessories Parallel Pin, Depth Gage, and Surgical Ratchet	Implant Integration Systems, Inc.	DZE	Class II	1998-01-16