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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2669 of 3530

510(k) clearances, page 2669 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K885227	Clinistat Hemoglobin Reagent Test	Kulzer GmbH	KHG	Class II	1989-02-24
K884999	Hold-Fast Denture Adhesive	Iodent, Co.	KOL	Class I	1989-02-24
K884688	Modular Spinal Fixation & Locking Hook Spinal Rod	Synthes (USA) Products LLC	KWP	Class II	1989-02-24
K883986	Cris Adapter	Y	FPA	Class II	1989-02-24
K890561	Spq(tm) Antibody Reagent Set II for Igm	Atlantic Antibodies	CFQ	Class II	1989-02-23
K890474	Surgical Gowns	Victoria Slipper Retail & Mfg., Co.	FYA	Class II	1989-02-23
K890461	Cardiobeeper IV	Survival Technology, Inc.	DXH	Class II	1989-02-23
K890447	Hemorrhage Occludor	Surgeon Surgical Instrumentation, Inc.	GDW	Class II	1989-02-23
K890428	Delfia Progesterone Kit	Pharmacia, Inc.	JLS	Class I	1989-02-23
K890298	Demand Nasal Oxygen Cannula Models 4008/4108/4208	Salter Labs	NFB	Class II	1989-02-23
K890109	Safepette Dispenser	Safe-Tec Clinical Products, Inc.	JKA	Class II	1989-02-23
K890079	Lifepak 10 Defibrillator/monitor	Physio Control, Inc.	LDD	Class II	1989-02-23
K890051	Biotrack Aptt Controls	Biotrack, Inc.	GIT	Class II	1989-02-23
K885341	Titan Gel Alkaline Phosphatase (Hr)	Helena Laboratories, Corp.	CIN	Class II	1989-02-23
K885306	Nuprep	Weaver & Co.	DRX	Class II	1989-02-23
K885198	17-Alpha-Hydroxyprogesterone (17-Oh-P) Neo. Ria	Icn Biomedicals, Inc.	JLX	Class I	1989-02-23
K885186	Heartstart 2000 Defibrillation Electrode	Laerdal Mfg. Corp.	LDD	Class II	1989-02-23
K885061	Siemens Intravaginal Transducer	Siemens Medical Solutions USA, Inc.	HEM	Class II	1989-02-23
K885000	Q750 Electrocardiograph	Quinton, Inc.	LOS		1989-02-23
K884949	Visible Light Cure Calcium Hydroxide Liner	Ortho Source	EJK	Class II	1989-02-23
K884934	Jedmed Kp6 Colposcope	JEDMED Instrument Company	HEX	Class II	1989-02-23
K884896	Bp-308 Mark II	Colin Medical Instruments Corp.	DPS	Class II	1989-02-23
K884885	Bp-408 Mark II	Colin Medical Instruments Corp.	DXN	Class II	1989-02-23
K884870	Teca/medelec 'Concept' P420	Teca, Inc.	GWF	Class II	1989-02-23
K884689	Dsl 7800 Active Cortisol	Diagnostic Systems Laboratories, Inc.	CGR	Class II	1989-02-23
K884550	Creatine Kinase Mb Enzyme Immunoassay Kit	BD Becton Dickinson Vacutainer Systems Preanalytic	JHY	Class II	1989-02-23
K884260	Thyroxine Microassay	Diamedix Corp.	KLI	Class II	1989-02-23
K884096	Patient Monitor Model 701	Ivy Biomedical Systems, Inc.	DRT	Class II	1989-02-23
K884087	High Resolution Option for Mac Series Electrocardi	Marquette Electronics, Inc.	LOS		1989-02-23
K884050	Cns-8200A Central Nurses Station	Nihon Kohden America Inc	DQA	Class II	1989-02-23
K883982	Drenovac	Iberhospitex, S.A.	GCY	Class I	1989-02-23
K874778	Kodak Ektascan Image Transmission Syst T1/r1 Sftwr	Eastman Kodak Company	LMA	Class II	1989-02-23
K890643	Vitalon Chair Massager Model V-Chr2	Nexus Co., Ltd. C/O Yama Trans Co., Ltd.	ISA	Class I	1989-02-22
K890562	Spq(tm) Antibody Reagent Set II for Hpt	Atlantic Antibodies	DAD	Class II	1989-02-22
K890416	Spq(tm) Antibody Reagent Set II for Igg	Atlantic Antibodies	DEW	Class II	1989-02-22
K890352	Multiskop	Siemens Medical Solutions USA, Inc.	IZI	Class II	1989-02-22
K885332	Coulter Flow Reticulocyte Reagent	Coulter Electronics, Inc.	GKL	Class II	1989-02-22
K885238	Curity Continuous Spinal Anesthesia Tray	The Kendal Co.	CAZ	Class II	1989-02-22
K885154	Intersept* Crystalloid Cardioplegia Deliv. System	Medtronic Blood Systems, Inc.	KRJ	Class II	1989-02-22
K884878	Solarettes	Dioptics	HQY	Class I	1989-02-22
K884871	Resound Hes, Digitally Progr., Ite Hearing Aid	Resound Corp.	ESD	Class I	1989-02-22
K884811	Accufix and Laserdish Bipolar Vs-1 Leads	Telectronics and Control Pacing Systems	DTB	Class III	1989-02-22
K884494	Daig Obturator, Catheter Introducer	Daig Corp.	DYB	Class II	1989-02-22
K884478	Daig Collapsible Sterile Sleeve	Daig Corp.	DQR	Class II	1989-02-22
K884422	Polyglucose Powder	Anthony N Silvetti, M.D., S.C.	FRO	Unclassified	1989-02-22
K884159	Softouch Introducer W/hemostasis Valve & Sideport	Mallinckroot, Inc.	DYB	Class II	1989-02-22
K884044	Audiometer Digital Hearing System	Resound Corp.	EWO	Class II	1989-02-22
K890625	James Reagent	Dms Products, Inc.	JTO	Class I	1989-02-17
K890616	Bion Direct Identification Control Slide	Bion Ent., Ltd.	LJG	Class I	1989-02-17
K890567	Bite Block #59430	Medi-Source, Inc.	JXL	Class II	1989-02-17