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 3231 of 3528

510(k) clearances, page 3231 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K821047	Ivac 630 & Volumetric Infusion Pump	Y	FRN	Class II	1982-05-03
K821040	Rapid Sst	Mds Laboratories, Inc.	JTO	Class I	1982-05-03
K821039	Uni-Pump 200	Scientific Mfg. Industries, Inc.	JQW	Class I	1982-05-03
K821034	Skatron Repeating Dispenser	Skatron, Inc.	JQW	Class I	1982-05-03
K821032	Model Sr-1020Lf	Stewart-Riess Labs	FPA	Class II	1982-05-03
K821031	Amerlex B-Lcg Ria Kit	Amersham Corp.	JHI	Class II	1982-05-03
K821030	Nova II Fluids Pack	Shaban Mfg. Co.	JIX	Class II	1982-05-03
K821027	Soft Tip Low Pressure Cuffed Oral/nasal	Shiley, Inc.	BTR	Class II	1982-05-03
K821011	Ace Activity Microvial Test Set	Ventrex Laboratories, Inc.	KQN	Class II	1982-05-03
K821007	Eclipse	Scientific Software & Instrument Co.	JQW	Class I	1982-05-03
K820996	Salmonella & Shigella Grouping Sera	Fisher Scientific Company L.L.C.	GRL	Class II	1982-05-03
K820992	Microplate Washing Device	Skatron, Inc.	JTC	Class I	1982-05-03
K820943	System I Infant Monitoring Sys	Burr Engineering & Development Co.	FLS	Class II	1982-05-03
K820942	Roche(r) B-Hcg Ria Urine Standard	Hoffmann-La Roche, Inc.	JHI	Class II	1982-05-03
K820913	Ra-1000 System Add'l Analytes Phase III	Technicon Instruments Corp.	CEK	Class II	1982-05-03
K820908	Teca Model Sensor Er 94	Teca, Inc.	GWF	Class II	1982-05-03
K820895	Cylomegalovirus Direct Fluorescent Anti	Bartels Immunodiagnostic Supplies, Inc.	LIN	Class II	1982-05-03
K820878	Concho Pediatric Pack	Rci, Inc.	BTT	Class II	1982-05-03
K820829	Medicam	M.P. Video, Inc.	FWB	Class I	1982-05-03
K820789	Cancan 2002 Dental Patient Chair	Time Motion System Co.			1982-05-03
K820778	Respiration Monitor 1000	Intl. Medical Devices, Ltd.	BZQ	Class II	1982-05-03
K820771	Microbiology Specimen Brush	Mill-Rose Laboratory	BTG	Class II	1982-05-03
K820732	La Vel Lateral View Extension Lens	Peter M. Tolliver	HOI	Class I	1982-05-03
K820692	Bandbag, Wrap, Sterile	Domico Med-Device, LLC	MMP	Class II	1982-05-03
K820665	Derma Prene	Ansell, Inc.	KGO	Class I	1982-05-03
K820663	Boger Auto-Traction Device	D.C. Medical Device, Inc.	ILZ	Class I	1982-05-03
K820264	Ams Gram-Positive Identification Card	Vitek Systems, Inc.	JTO	Class I	1982-05-03
K813497	Rhythm Wheel	Tropical Enterprises, Inc.	LHD	Unclassified	1982-05-03
K821067	Vivonex Acutrol Enternal Feeding Sys	Norwich Eaton Pharmaceuticals, Inc.	KNT	Class II	1982-04-29
K821066	Contour II Link Sp Total Hip Prosthesis	C.R. Bard Inc	JDI	Class II	1982-04-29
K821062	Hematoxylin Solution	Sigma Chemical Co.	HYJ	Class I	1982-04-29
K821049	Paratherm	American Thermometer Company, Inc.	KYA	Class I	1982-04-29
K821046	Compres Portable Heat Pads	S.C. Johnson & Son, Inc.	IMD	Class I	1982-04-29
K821029	Arthroscopy System Leg Holder	Zimmer GmbH	FWZ	Class I	1982-04-29
K821018	Antihuman Igg Globulin Fitc Labeled	Microbiological Research Corp.	DEW	Class II	1982-04-29
K820986	EKG Monitors, Various Models	Dart Medical Equipment	DXH	Class II	1982-04-29
K820971	Diathermic Handle for Biopsy Forceps	Mill-Rose Laboratory	GEI	Class II	1982-04-29
K820952	Opti-Mist	Corpak Co.	CAF	Class II	1982-04-29
K820949	P-S Berlin Vessel Clamp	Pudenz-Schulte Medical Research Corp.	DXC	Class II	1982-04-29
K820946	As 70 Volumetric Infusion Pump	Narco Scientific	FRN	Class II	1982-04-29
K820936	Moisture Trap	Dhd Medical Products Div. Diemolding Corp.	BYH	Class I	1982-04-29
K820884	Electrical Muscle Stimulator	Nitron Electronics	IPF	Class II	1982-04-29
K820883	Septisleeve	Argon Medical Corp.	DYG	Class II	1982-04-29
K820856	Eventmaster 2	Instruments for Cardiac Research	DSI	Class II	1982-04-29
K820822	Tandem Hcg Kit	Hybritech, Inc.	JHI	Class II	1982-04-29
K820820	Cardio Revue Center	Diasonics, Inc.	DXG	Class II	1982-04-29
K820814	Thermo-K	American Medical Systems, Inc.	DWJ	Class II	1982-04-29
K820758	Boundary Single-Use Craniotomy Sheet	The Buckeye Cellulose Corp.	KKX	Class II	1982-04-29
K820695	Automatic Dialyzer Reprocessor #Adr-22	Texas Medical Devices, Inc.	LIF	Class II	1982-04-29
K820651	Model 860-1 Veri/probe	Verite	GZJ	Class II	1982-04-29