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 3426 of 3526

510(k) clearances, page 3426 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K781780	Catheter, External Male Nursing Care	Medi-Tech, Inc.	KNX	Class II	1978-12-07
K781767	Instrument Curnett Mini-Coner Biopsy	C.R. Bard Inc	KOH	Class I	1978-12-07
K781766	Uterine Sound, Burnett Disposable	C.R. Bard Inc	HHM	Class I	1978-12-07
K781744	IV Set with Graduated Chamber	National Patent Development Corp.	FPA	Class II	1978-12-07
K781738	Pacemaker, Model 229-01	Intermedics, Inc.	DXY	Class III	1978-12-07
K781693	Collagenreagent Horm	Hormon-Chemie Munchem Gmch	JOZ	Class II	1978-12-07
K781649	Ultrasonic Transducers	Echo Laboratories, Inc.	ITX	Class II	1978-12-07
K781641	Surgitek Double J Ureterol Stent	Medical Engineering Corp.	FAD	Class II	1978-12-07
K781633	Ultrafiltration Scale	Extracorporeal Medical Specialities, Inc.	FIL	Class II	1978-12-07
K781569	Nerve Locater/stimulator	Intermedics, Inc.	ETN	Class II	1978-12-07
K781549	Toxelisa Test Kit	Microbiological Assoc.	GLZ	Class II	1978-12-07
K781455	Siemens Ultratherm 708	Elmed, Inc.	IMJ	Class II	1978-12-07
K781405	Suitcase Kidney Hemodialysis System	Union Carbide Corp.	FKP	Class II	1978-12-07
K780961	Theophylline Control Serum	Vitek Systems, Inc.	LAS	Class I	1978-12-07
K780960	Serum, Control, Drugs, Antiarrythmic	Vitek Systems, Inc.	DIF	Class I	1978-12-07
K780897	Generator, Pulse, Sorin Model Dl-1	Bentley Laboratories, Inc.	DXY	Class III	1978-12-06
K782000	Monitor, Non-Invasive Blood Pressure	Automated Screening Devices	DXN	Class II	1978-12-05
K781746	Minico	Catalyst Research Corp.	CCJ	Class II	1978-12-05
K781731	Incent-O-Neb	B & F Medical Products, Inc.	BWF	Class II	1978-12-05
K781437	Surgical Prep Razor	Warren J. Grosjean	LDQ		1978-12-05
K781990	Cardiac Insulation Pad	Shiley, Inc.	DWF	Class II	1978-12-04
K781987	Urinary Drainage Bag	Kelsar Corp.	KNY	Class II	1978-12-04
K781984	Collimator, Heart Contour	Siemens Corp.	KPW	Class II	1978-12-04
K781983	Exploramat, Cosmic 2	Siemens Corp.	KPR	Class II	1978-12-04
K781982	Inclinometer, Vermont	Associates in Radiology, Inc.	IZL	Class II	1978-12-04
K781976	Mobile X-Ray Unit	General X-Ray, Inc.	IZL	Class II	1978-12-04
K781975	Mobile Carrier	General X-Ray, Inc.	IZL	Class II	1978-12-04
K781955	Gun, Cement	Depuy, Inc.	KIH	Class I	1978-12-04
K781947	Stroller, Therapy	Convaid Products LLC	LBE	Class I	1978-12-04
K781943	Tendon Rod Model Or41po3-6	Holter-Hausner Intl.	HXA	Class II	1978-12-04
K781942	Miniwash	Dynatech Laboratories, Inc.	JTC	Class I	1978-12-04
K781936	Scanner-Emi 7020 and 7020R	Emi Medical, Inc.	JAK	Class II	1978-12-04
K781934	Processor, Model M8	Eastman Kodak Company	IXW	Class II	1978-12-04
K781933	Dispensor, Xenon Gas	Diagnostic Isotapes, Inc.	IYT	Class II	1978-12-04
K781920	Valve, Vent-Away Two-Way	Chesebrough-Pond'S U.S.A. Co.	CBP	Class II	1978-12-04
K781919	Plaque Detection System	Clairol, Inc.	NYH	Class II	1978-12-04
K781917	Mucus Aspirator	Ovutime, Inc.	FMF	Class II	1978-12-04
K781913	Insuffalator Laparaoscopic	Kli	HIF	Class II	1978-12-04
K781892	Locator, Foreign Body	Keeler Optical Products, Ltd.	HPM	Class II	1978-12-04
K781890	Chamber, Mc-1 Disposable Pressure	Delta Medical Industries	DXS	Class II	1978-12-04
K781883	Diluter, Lsa 290 Pipetter	Kallestad Laboratories, Inc.	JQW	Class I	1978-12-04
K781880	Assay Kit, Thrombo-Screen	Pacific Hemostasis	GIS	Class II	1978-12-04
K781865	Iron Binding Capicity Model 0370	Stanbio Laboratory	JIY	Class I	1978-12-04
K781860	Assay, Chromogenic Antithrombin III	Ortho Diagnostics, Inc.	JBQ	Class II	1978-12-04
K781859	Reagent System, No 46-Ov for Cpk	Sigma Chemical Co.	CGS	Class II	1978-12-04
K781854	Pad, B-D i.v. Cath.	BD Becton Dickinson Vacutainer Systems Preanalytic	KGZ	Class I	1978-12-04
K781853	Cholesterol Standards	BD Becton Dickinson Vacutainer Systems Preanalytic	JIS	Class II	1978-12-04
K781849	Electrodes, Implantable with Adapter	Telectronics, Inc.	DTB	Class III	1978-12-04
K781836	Telemetry System, Biotel 300	Spacelabs, Inc.	DRG	Class II	1978-12-04
K781828	Computer, 3500, Gilford System	Syva Co.	KLI	Class II	1978-12-04