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 2026-10-08, 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 3453 of 3526

510(k) clearances, page 3453 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K780474	Audiometer Calibrator Model Ra 310	Tracor Instruments, Inc.	EWA	Class I	1978-03-30
K780459	Cleartone Model-1 & 2 Hearing Aids	Cleartone Custom Hearing Instruments	ESD	Class I	1978-03-30
K780450	Tracor Ra 410 Audiometer	Tracor Instruments, Inc.	EWO	Class II	1978-03-30
K780428	Roche Tsh Ria	Hoffmann-La Roche, Inc.	JLW	Class II	1978-03-30
K780423	Stiksep-T4 Ria Kit	Nuclear Diagnostics, Inc.	CDX	Class II	1978-03-30
K780365	Oxygen/nitrous Oxide Outlet	Spica, Inc.	CAM	Class I	1978-03-30
K780364	Manifold Kit	Spica, Inc.	CAN	Class I	1978-03-30
K780303	Auto ISO-Filter Collection Tube Cap	BD Becton Dickinson Vacutainer Systems Preanalytic	GJE	Class II	1978-03-30
K780285	Soluble Collagen	General Diagnostics	JOZ	Class II	1978-03-30
K780189	Platelet Rotator	Travenol Laboratories, S.A.	KSQ	Class I	1978-03-30
K780404	ECG Monitoring System,	Quinton, Inc.	DRT	Class II	1978-03-28
K780334	Adhesive, Bracket and Conditioner Resin	Rocky Mountain Orthodontics, Inc.	DYH	Class II	1978-03-28
K780294	G Wrap	Cel-Fibe	FRG	Class II	1978-03-28
K780256	Hdl Cholesterol Method	Helena Laboratories, Corp.	JHO	Class I	1978-03-28
K780253	Reagent System, Aria II T3 Uptake	BD Becton Dickinson Vacutainer Systems Preanalytic	KHQ	Class II	1978-03-28
K780222	i.v. Start Kit	Marion Laboratories, Inc.	FRO	Unclassified	1978-03-28
K780419	Subclavian Tray	Concord Laboratories, Inc.	KGO	Class I	1978-03-27
K780400	Den-Z-Orb	Nice-Pak Products, LLC	KHR	Class I	1978-03-27
K780350	i.v. Start Kit	BD Becton Dickinson Vacutainer Systems Preanalytic	FOZ	Class II	1978-03-27
K780305	Cell	Dynatech Laboratories, Inc.	KJF	Class I	1978-03-27
K780245	Recorder, Re-100P Hot Stylus Strip Chart	Waters Assoc., Inc.	DSF	Class I	1978-03-27
K780242	Spectrophotometer, Fluorescence M.650-10	Revvity Health Sciences, Inc.	KHO	Class I	1978-03-27
K780203	Thromboplastin Dried	Hyland Therapeutic Div., Travenol Laboratories	GJS	Class II	1978-03-27
K780163	Redi-Disc Hemoglobin Gel Tube Kit	Miles Laboratories, Inc.	JBD	Class II	1978-03-27
K780162	Digaphot Phototherapy Meter Model Pt 145	Cavitron Corp.	FTA	Class II	1978-03-27
K780140	Cell-Chex	Streck Laboratories, Inc.	JPK	Class II	1978-03-27
K772017	In Vitro Theophylline Ria Test	Clinical Assays, Inc.	KLS	Class II	1978-03-27
K780408	Micronet Light Dressing Sponge	Kendall Research Center	NAB	Class I	1978-03-22
K780397	Orthopedic Forceps	Orthopedic Equipment Co., Inc.	HTX	Class I	1978-03-22
K780396	Nasal Gastric Tube Retainer	Mor-Mac, Inc.	FPK	Class II	1978-03-22
K780390	Spectrophotometer, Absorption, Atomic	Varian Assoc., Inc.	JXR	Class I	1978-03-22
K780388	Analyzer, 100, Bichromatic, Abbott	Syva Co.	JJE	Class I	1978-03-22
K780383	Counter, Radioassay, Auto., Micromedic	Micromedic Systems	JJJ	Class I	1978-03-22
K780362	Spectrofluorometer Sf-330	Varian Assoc., Inc.	KHO	Class I	1978-03-22
K780361	T3 Uptake Test	Monobind, Inc.	KHQ	Class II	1978-03-22
K780346	Mif Procedure Kit	Marion Laboratories, Inc.	JTS	Class I	1978-03-22
K780335	Las-R Human C1 Esterase Inhibitor Test	Hyland Therapeutic Div., Travenol Laboratories	DBA	Class II	1978-03-22
K780332	Cathode Ray Tube Display Model 1340A	Hewlett-Packard Co.	DXK	Class II	1978-03-22
K780398	Cup, Acetabular, Long Posterior Wall	Orthopedic Equipment Co., Inc.	JDI	Class II	1978-03-21
K780363	Phonic Ear	Hc Electronics	ESD	Class I	1978-03-21
K780158	Teletrace Telephone EKG Transmitter	Medtronic, Inc.	DXH	Class II	1978-03-21
K780399	Instrument Cleaning Brush	Ransom & Randolph. LLC.	KDC	Class I	1978-03-17
K780329	Total Hip, New England Baptist	Depuy, Inc.	JDG	Class II	1978-03-17
K780325	Rid System-Human C-Reactive Protein	Icl Scientific	DEN	Class I	1978-03-17
K780323	Quantitope 125-I Gentamicin Ria Kit	Kallestad Laboratories, Inc.	DJB	Class II	1978-03-17
K780320	Passive Tendon Implant	Holter-Hausner Intl.	HXA	Class II	1978-03-17
K780316	Rabbit Antibody to Digoxin	Pcl-Ria, Inc.	DKA	Class II	1978-03-17
K780306	Lyophilized Vials of Vca and Vcat	Gibco Laboratories Life Technologies, Inc.	JSK	Class I	1978-03-17
K780283	Inserter, Plug, Bone, Lidge	Depuy, Inc.	LGF	Class I	1978-03-17
K780185	Oxygen Analyzer 110	Siemens Corp.	CCC	Class II	1978-03-17