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 2026-10-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3519 of 3526

510(k) clearances, page 3519 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K760650	Retractor, Gerbode Sternal	Dilling Co.	GAP	Class II	1976-09-21
K760648	Tibial Artery Clamp W/atraugrip Jaws	Pilling Co.	DWS	Class I	1976-09-21
K760646	Carotid Artery Clamp W/pilling Lmm	Pilling Co.	DWS	Class I	1976-09-21
K760645	Carotid Artery Arteriotomy Closure Clamp	Pilling Co.	DWS	Class I	1976-09-21
K760635	Medi-Dyne Apnea Monitor	Med Dyne Inst., Inc.	FLS	Class II	1976-09-21
K760620	Saliva Ejector	Lorvic Corp.	DYN	Class I	1976-09-21
K760612	Spacelabs Series 1000	Spacelabs, Inc.	DPS	Class II	1976-09-21
K760611	3M Brand Anesthesia Filter,#3110	3M Company	CAH	Class II	1976-09-21
K760609	Eyeglass Hearing Aid	Zenith Hearing Instrument Co.	ESD	Class I	1976-09-21
K760602	Sorvall Embedding Medium	E.I. Dupont de Nemours & Co., Inc.	KEO	Class I	1976-09-21
K760580	Drug Nebulizer	Ohio Medical Products	CCQ	Class I	1976-09-21
K760570	Robinson Middle Ear Prosthesis	Xomed, Inc.	EIB	Class I	1976-09-21
K760438	Spoon-Bobbin Drain Tube W/ Wire, Otology	Richard'S Medical Equip., Inc.	ETD	Class II	1976-09-21
K760104	Respiration Monitor	Air-Shields, Inc.	FLS	Class II	1976-09-21
K760026	Ultrazyme Amylase	Harleco	CIJ	Class II	1976-09-21
K760624	Small Vessel Cannula	Cobe Laboratories, Inc.	DWS	Class I	1976-09-17
K760595	Cardiac Probe	G.D. Searle and Co.	IZD	Class I	1976-09-17
K760593	Portable Cardiac Monitor, Abby	Abbott Medical	DRT	Class II	1976-09-16
K760565	Ventilator Circuits	Foregger Air Products & Chem., Inc.	CAI	Class I	1976-09-16
K760441	Body Warmer (Shake-N-Warm)	Yamada Co., Ltd of Japan	IMD	Class I	1976-09-16
K760599	Dental Chairs	Chayes Virginia, Inc.	KLC	Class I	1976-09-15
K760571	Floss-a-Lot	E. T. Skinner	JES	Class I	1976-09-15
K760569	Three Phase X-Ray Controls & Hv Generators	Litton Medical Systems	IZO	Class I	1976-09-15
K760568	Single Phase X-Ray Controls & Hv Generators	Litton Medical Systems	IZO	Class I	1976-09-15
K760567	Bacteria Filter	Foregger Air Products & Chem., Inc.	CAH	Class II	1976-09-15
K760491	Tumbler, General Medical Medi-Pak	Landmark Plastics	LDR	Class II	1976-09-15
K760482	Sunlamp (F40-Uvb & F20-Uvb)	Dermatron Corp.	FTC	Class II	1976-09-15
K760481	Filter, Particulate Arresting	Miles Laboratories, Inc.	FRF	Class II	1976-09-15
K760471	Lamp, Flourescent Black, High Output	Dermatron Corp.	FTC	Class II	1976-09-15
K760423	Electrolysis Machine (Permatron)	Epco Hair Removal Corp.	KCX	Class I	1976-09-15
K760251	Set, Oral Administration	Cis Radiopharmaceuticals, Inc.	LEY	Class II	1976-09-15
K760029	Enzymatic Triglyceride	Harleco	CDT	Class I	1976-09-15
K760028	Cpk - Isoenzymes	Harleco	JHT	Class II	1976-09-15
K760604	Eureka X-Scan 150 X-Ray Tube Housing as.	Eureka X-Ray Tube Corp.	ITY	Class I	1976-09-13
K760453	Regulator, Pressure, Cuff	Boehringer Laboratories, LLC	JOH	Class II	1976-09-13
K760425	Tampon, Playtex 2 Version a	Intl. Playtex, Inc.	HIL	Class II	1976-09-13
K760364	Handle, Scalpel, Stainless Steel	Aeroceuticals	GES	Class I	1976-09-13
K760363	Scalpel, Surgical, Sterile Stainless	Aeroceuticals	GES	Class I	1976-09-13
K760362	Lancet, Blood, Sterile Stainless Steel	Aeroceuticals	KDC	Class I	1976-09-13
K760361	Blade, Surgical Scalpel, Sterile	Aeroceuticals	GES	Class I	1976-09-13
K760057	Test, Ria, Triodothyronine	Smithkline Diagnostics, Inc.	CDP	Class II	1976-09-13
K760030	Clinicard Phosphorus	Harleco	CEO	Class I	1976-09-13
K760564	Demodulator Series 1400	Physio Control, Inc.	DXH	Class II	1976-09-10
K760563	ECG Modulator	Physio Control, Inc.	DXH	Class II	1976-09-10
K760559	Patient Monitoring System	General Electric Co.			1976-09-10
K760542	Electrocardiograph (#1505A)	Hewlett-Packard Co.	DPS	Class II	1976-09-09
K760539	Recorder (#78640A)	Hewlett-Packard Co.	DSF	Class I	1976-09-09
K760533	Catheter, Flow Directed Thermal Dilution	Gould, Inc.	DYG	Class II	1976-09-09
K760532	Computer, Cardiac Output (#Sp1425)	Gould, Inc.	DXG	Class II	1976-09-09
K760427	Catheter, Dover Suction W/ Glove	Will Ross Co.	BSY	Class I	1976-09-09