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 2026-10-05, 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 3508 of 3526

510(k) clearances, page 3508 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K761167	Enema Kit	American Hospital Supply	FCE	Class I	1976-12-09
K761166	Tc-1 Cardiac Output Computer	Waters Assoc., Inc.	DXG	Class II	1976-12-09
K761162	Brachial Plexus Block Anesthesia Kit	Arrow Intl., Inc.	CAZ	Class II	1976-12-09
K761160	Model Cna-1 Vaporizer	Cyprane North America, Inc.	CAD	Class II	1976-12-09
K761156	Aminoglycoside Controls	Supelco, Inc.	DAS	Class I	1976-12-09
K761154	Glucose Oxidase Reag for Beckman Analyz	Advanced Biomedical Methods, Inc.	CGA	Class II	1976-12-09
K761153	Gluc Opap, in Vitro Diag. for Glucose	Advanced Biomedical Methods, Inc.	CGA	Class II	1976-12-09
K761152	S-Urea-N, in Vitro Diag for Bun	Advanced Biomedical Methods, Inc.	CDL	Class II	1976-12-09
K761151	Infusion Pump	Travenol Laboratories, S.A.	FRN	Class II	1976-12-09
K761149	Model 203 Dispenser	Beckman Instruments, Inc.	JTC	Class I	1976-12-09
K761140	Fraser Sweatman's Double Mask	Fraser Sweatman, Inc.	CBN	Class II	1976-12-09
K761079	Flexible Tip Aspirating Tubes	Pilling Co.	BYY	Class II	1976-12-09
K761066	ECG Monitor (Telephone ECG Transmitter)	Physio Control, Inc.	DXH	Class II	1976-12-09
K761057	Arteriosonde Blood Press. Mntr. (#1020)	Roche Medical Electronics, Inc.	DXN	Class II	1976-12-09
K761056	Display Monitor (Model 78301A)	Hewlett-Packard Co.	DRR	Class II	1976-12-09
K761055	Calculator Plotter (Model 9872A)	Hewlett-Packard Co.	DSF	Class I	1976-12-09
K761041	Powered Treadmill (30/St)	Physio Control, Inc.	IOL	Class I	1976-12-09
K761040	Powered Treadmill (20/St)	Physio Control, Inc.	IOL	Class I	1976-12-09
K761012	Alphabed Alternating Pressure Pad	Nlowtron-Aire, Ltd.	FNM	Class II	1976-12-09
K760993	Meck/miller Ventilation Tube Harness	Timeter Instrument Corp.	BZO	Class I	1976-12-09
K760989	Uric Acid Reagent Set	Worthington Biochemical Corp.	CDO	Class I	1976-12-09
K760971	Positive Displacement Spirometer	Boehringer Laboratories, LLC	BZK	Class II	1976-12-09
K760964	Addi-Mist	Respiratory Care, Inc.	CAF	Class II	1976-12-09
K760948	Thermo Finer Coretemp	Terumo America, Inc.	FLL	Class II	1976-12-09
K760895	Automatic Shut-Off Valve	Delta Medical Industries	KZD	Class I	1976-12-09
K760894	Vacuum Relief Valve	Delta Medical Industries	DWD	Class II	1976-12-09
K760891	Inspiron I.m.v. Set Up	Inspiron Corp.	CBO	Class II	1976-12-09
K760886	Rectal Tube Device	Van Sickle Plastics Co.	EXB	Class I	1976-12-09
K760884	Micro-Computer Arrhythonia System	Spacelabs, Inc.	DSI	Class II	1976-12-09
K760877	Monoject Laryngotracheal Anesthesia Kit	Sherwood Medical Industries	CCT	Class II	1976-12-09
K760876	Argyle IV Starter Kit (W/o Drug)	Sherwood Medical Industries	LRS	Class II	1976-12-09
K760760	Catheter, Intravascular (Argyle IV Sk)	Sherwood Medical Industries	JCY	Class I	1976-12-09
K760759	Anesthesia Kit	Sherwood Medical Industries	CCT	Class II	1976-12-09
K760642	Analyzer, Programmable Discrete (Pda)	Anatronics Corp.	JJE	Class I	1976-12-09
K761161	67-8006 Darling-Linton Aortic Tourn.	Cerenovus, Inc.	DWS	Class I	1976-12-06
K761159	Portacamera 11-B	General Electric Co.	IYX	Class I	1976-12-06
K761144	Fem Cath (Urethral Catheter)	Mallinckrodt Critical Care	KOD	Class II	1976-12-06
K761100	Multi-Cell Ultrafiltration System	Amicon, Inc.	JQQ	Class I	1976-12-06
K761087	Electronic Control Unit	Gorman Rupp Industries	DWJ	Class II	1976-12-06
K761082	Single Needle Hemodialysis (Bfc-142)	Sorensen Research	KOC	Class II	1976-12-06
K761081	Single Needle Hemodialysis (Bfc-161)	Sorensen Research	KOC	Class II	1976-12-06
K761078	Hemo-Cath I, Kidney Dialysis Catheter	Medical Disposables Intl., Inc.	KOC	Class II	1976-12-06
K761038	Single Needle Hemodialysis	Sorensen Research	KOC	Class II	1976-12-06
K761014	Cardiart 108T/313	Conway Electronic Enterprises, Ltd.	DPS	Class II	1976-12-06
K761001	Pap-Tray II (Catalog #C600-2)	Lerner Laboratories, Inc.	LEA	Class I	1976-12-06
K761000	Pap-Tray I (Catalog #C600-1)	Lerner Laboratories, Inc.	LEA	Class I	1976-12-06
K760965	Bedside Consoles (11-3-910 & 11-3-930)	Seattle Artificial Kidney Supply Co.	FKQ	Class II	1976-12-06
K760858	Rutner Universal Wedge Catheter	Cook, Inc.	KOD	Class II	1976-12-06
K760781	Triex-1 Hollow Fiber Dialyzer	Extracorporeal Medical Specialities, Inc.	FJT	Class II	1976-12-06
K760743	Donormatic (Blood Collection Device)	Lifeline Instruments, Inc.	KSQ	Class I	1976-12-06