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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2920 of 3529

510(k) clearances, page 2920 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K860249	The Holter Reporter (Tm)	Applied Cardiac Systems	DPS	Class II	1986-03-11
K860156	Neisseriastat	Richardson Scientific, Inc.	JTO	Class I	1986-03-11
K860055	Mentor Single Coil Urinary Diversion Stent Set	Mentor	FAD	Class II	1986-03-11
K855143	Angiomed Exchange Drainage Catheter Sets	Angiomed U.S., Inc.	KOD	Class II	1986-03-11
K855142	Angiomed Percutaneous Transhepatic Cholangiogtaphy	Angiomed U.S., Inc.	FGE	Class II	1986-03-11
K855137	Curity Fiberoptic Intubating Airway	The Kendal Co.	CAE	Class I	1986-03-11
K855076	Angiomed Ureter Diation Sets	Angiomed U.S., Inc.	KOD	Class II	1986-03-11
K855034	American Histo-Id Sys Primary Kit Psa Prostate Ant	Bartels Immunodiagnostic Supplies, Inc.	LIJ	Class I	1986-03-11
K854929	Oxoid Streptococal Grouping Kit	Oxoid U.S.A., Inc.	GTZ	Class I	1986-03-11
K854918	Model 431-01 Biopore Implantable Pacing Lead	Intermedics, Inc.	DTB	Class III	1986-03-11
K854917	Model 435-01 Cardifix Implantable Pacing Lead	Intermedics, Inc.	DTB	Class III	1986-03-11
K854881	Sirecust 341 and 341R	Siemens Medical Solutions USA, Inc.	DRT	Class II	1986-03-11
K854029	Respiratory Resuscitation Device	John H. Harrison	CAE	Class I	1986-03-11
K853809	Daily Hard Contact Lens Cleaner	Maurry Biological Co.	HPX	Unclassified	1986-03-11
K853808	Hard Contact Lens Cleaning & Soaking Solution	Maurry Biological Co.	HPX	Unclassified	1986-03-11
K853318	Patient Monitor Pb240	Medtronic, Inc.	DRT	Class II	1986-03-11
K860762	Gamma-Free Horse Serum	Flow Laboratories, Inc.	KIS	Class I	1986-03-10
K860752	Goat Serum (29-391-54)	Flow Laboratories, Inc.	KIS	Class I	1986-03-10
K860750	Pseudomonas Agar P (Medium a)	Gibco Laboratories Life Technologies, Inc.	JSH	Class I	1986-03-10
K860591	Ace Multiple Pin Plate	Buckman Co., Inc.	HRS	Class II	1986-03-10
K860534	Bile Endoprosthesis Set	Angiomed U.S., Inc.	GBZ	Class I	1986-03-10
K860521	Standard Wheelchairs	Formotion, Inc.	IOR	Class I	1986-03-10
K860507	Harbor Medical Dressing Tray	Harbor Medical Inc.			1986-03-10
K860506	Harbor Medical Respiratory Tray	Harbor Medical Inc.			1986-03-10
K860446	C Arm Surgical Table	Medi-Mech, Inc.	FWZ	Class I	1986-03-10
K860179	Cellmatics Chlamydia Monoclonal Dfa Reagent	Difco Laboratories, Inc.	LJP	Class I	1986-03-10
K860133	Modified Synatomic Variable Fit Tibial Plateau	Depuy, Inc.	HRY	Class II	1986-03-10
K860062	Oculab Pachpen	Oculab, Inc.	IYO	Class II	1986-03-10
K860061	Oculab Biometricpen	Oculab, Inc.	IYO	Class II	1986-03-10
K855072	Maximus Cushion	Jay Medical, Ltd.	KIC	Class I	1986-03-10
K854720	Nemectrodyn Model 2 & Endovac 2 Power Muscle Stim.	Nemectron Medical, Inc.	IPF	Class II	1986-03-10
K854641	Solar F	Alpine Dental Equipment Co.	EIA	Class I	1986-03-10
K854529	Inlay Wax Regular	The Hygenic Company, LLC	EGD	Class I	1986-03-10
K854407	Digirad Reusable Image Media	Digirad Corp.	LQA	Class I	1986-03-10
K854107	Dimension Total Hip Prosthesis Porous Coated	Kirschner Medical Corp.	JDL	Class III	1986-03-10
K852739	Sonoline Sx Ultrasound Scanner	Siemens Medical Solutions USA, Inc.	DXK	Class II	1986-03-10
K852686	Sonoline Cd	Siemens Medical Solutions USA, Inc.	IYO	Class II	1986-03-10
K852346	Xiscan Model 1000	Xi Tech	JAA	Class II	1986-03-10
K860590	Ace Unilateral Fixator	Buckman Co., Inc.	HTY	Class II	1986-03-07
K860158	8-Channel Multiprog Implant Spinal Cord Stimulator	Neuromed, Inc.	GZB	Class II	1986-03-07
K855081	Phoenix Models 250/251 Pulse Generators	Pacesetter Systems	DXY	Class III	1986-03-07
K854974	Hsv Idr	Genus Diagnostics	GQN	Class II	1986-03-07
K854964	Cadd-Ld 5500 Ambu Infusion Pump&3010 10Ml Med Res.	Deltec Systems, Inc.	FRN	Class II	1986-03-07
K854621	Isostation Knee Machine (K-100)	Isotechnologies, Inc.			1986-03-07
K860755	Kodak Min-R Fast Screen So-459	Eastman Kodak Company	EAM	Class I	1986-03-06
K860754	Kodak T-Mat M Film So-245	Eastman Kodak Company	IXA	Class II	1986-03-06
K860666	Kodak X-Omat Processor, Model Me-3	Eastman Kodak Company	IXW	Class II	1986-03-06
K860655	Kultsure (Catalogue No. M200)	Ncs Diagnostics, Inc.	LIO	Class I	1986-03-06
K860596	Sweet Dreems Simulator	Sweet Dreams, Inc.	FMS	Class II	1986-03-06
K860306	Bt-795/P Automated Autotrans	Electromedics, Inc.	CAC	Class II	1986-03-06