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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3100 of 3528

510(k) clearances, page 3100 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K834087	Model Xle	Interad Systems, Inc.	IYO	Class II	1984-02-27
K833943	Meniscal Suturing System	Dyonics, Inc.	LXH	Class I	1984-02-27
K833855	Titan Gel Silver Stain System	Helena Laboratories, Corp.	CEF	Class I	1984-02-27
K833640	Hydroxyline	George Taub Products & Fusion Co., Inc.	EJK	Class II	1984-02-27
K833635	Biosonics Salivary Tester	Meyer, Faller & Weisman			1984-02-27
K833057	Universal Fix-a-Plate	Laurentian Laboratories	EBO	Class II	1984-02-27
K833056	Universal Line-a-Plate	Laurentian Laboratories	EBO	Class II	1984-02-27
K832311	Hemoccult-C	Menley & James Laboratories	KHE	Class II	1984-02-27
K840851	Viral Transport Medium	Bartels Immunodiagnostic Supplies, Inc.			1984-02-24
K840179	Continuous Epidural Anesthes. Tray	Burron Medical Products, Inc.	CAZ	Class II	1984-02-24
K840345	Impulse Ventilator	Healthdyne, Inc.	CBK	Class II	1984-02-23
K840314	Cat 10-Neurology Device	Imm Enterprises, Ltd.	GWZ	Class I	1984-02-23
K840287	Brachial Plexus Anesthesia Tray	Burron Medical Products, Inc.	CAZ	Class II	1984-02-23
K834178	H.r. Jakobi Surg. Instr. #10 34/36	Imm Enterprises, Ltd.	GWZ	Class I	1984-02-23
K834170	Op-Con Surg. Instrument #10	Imm Enterprises, Ltd.	GWZ	Class I	1984-02-23
K840535	Dispos. Anesthesia Face Mask	Marquest Medical Products, Inc.	BSJ	Class I	1984-02-21
K840500	Sediplast	Precision Technology, Inc.	JPH	Class I	1984-02-21
K840482	Male Insert Slip	Beghin_Say Intl., Inc.	EYQ	Class I	1984-02-21
K840463	Digital Cradle	Spectrum X-Ray Corp.	KXH	Class I	1984-02-21
K840437	Hemasite Accessories Modification	Renal Systems, Inc.	KNZ	Class II	1984-02-21
K840436	Hemasite/renaloy -Vascular Access Shunt	Renal Systems, Inc.	FIQ	Class II	1984-02-21
K840390	Technicare Model 1047	Technicare Corp.	JAA	Class II	1984-02-21
K840389	Sep Programmer Sep-M/single-Plane &	Elema-Schonander, Inc.	IZP	Class II	1984-02-21
K840359	Post-Auricular Hearing Aid	Phonic Ear, Inc.	ESD	Class I	1984-02-21
K840261	Cal-Chex, a Hematology Calibrator	Streck Laboratories, Inc.	KRZ	Class II	1984-02-21
K840224	Extended Life Capd Solution Transfer	Travenol Laboratories, S.A.	FKX	Class II	1984-02-21
K840131	Computed Tomography Calibration Phant	Imatron, Inc.	IXG	Class I	1984-02-21
K840128	Counter Model S880	Coulter Electronics, Inc.			1984-02-21
K840083	Sterile Insulin Dispos. Needle/green	Lee Medical Intl., Inc.	FMF	Class II	1984-02-21
K840082	Sterile Insulin Dispos. Needle/syringe	Lee Medical Intl., Inc.	FMF	Class II	1984-02-21
K840081	IV Administration Set	Lee Medical Intl., Inc.	FPA	Class II	1984-02-21
K834611	Singul-Xr Rp Non Screen Med. Film	Cea America Corp.	IWZ	Class I	1984-02-21
K834607	Electronic Kvp Cassette	Radiation Measurements, Inc.	IWN	Class I	1984-02-21
K834606	X-Ray Collimator X-Cjd	Knochen Dental Laboratory	EHB	Class I	1984-02-21
K834559	Deluxe Wall-Mounted Cephalometer	Knochen Dental Laboratory	IWY	Class I	1984-02-21
K834538	Las-2 Alignment System	Therados, Inc.	KPO	Class II	1984-02-21
K834528	Model 2001 Intelligent Infusor	Quest Medical, Inc	LDR	Class II	1984-02-21
K834512	Sandmill Rms	Diversatek Healthcare Inc	FFT	Class I	1984-02-21
K834503	Profile Urodynamic Monitoring Sys	Browne Medical, Inc.	FAP	Class II	1984-02-21
K834496	Isorex Ls-36	Elscint, Inc.	IZI	Class II	1984-02-21
K834494	Spectrum X-Ray Corp	Spectrum X-Ray Corp.	IZZ	Class II	1984-02-21
K834487	Flexible Liquid Light Guide	Endo Lase, Inc.	FFS	Class II	1984-02-21
K834484	Cronex Sr-337	E.I. Dupont de Nemours & Co., Inc.	EAM	Class I	1984-02-21
K834478	Chick/reison Patient Emerg. Trolley	Professional Medical Products, Inc.	KXJ	Class II	1984-02-21
K834465	Series of Diagnostic Phantoms	Cirs, Inc.	IXG	Class I	1984-02-21
K834435	Crown & Bridge Resin	Rohm and Haas Co.	EBI	Class II	1984-02-21
K834396	Direct Iron Reagent Set	Seragen Diagnostics, Inc.	CFM	Class I	1984-02-21
K834348	Leeco T3-Quant Diag. Kit	Leeco Diagnostics, Inc.	CDP	Class II	1984-02-21
K834336	Flow-Pac Calcium Reagent Set	American Research Products Co.	CIC	Class II	1984-02-21
K834333	Flow-Pac Chloride Reagent Set	American Research Products Co.	CHJ	Class II	1984-02-21