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 3213 of 3528

510(k) clearances, page 3213 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K821671	Dispo. Aes.	Hiraoka New York, Inc.	FMF	Class II	1982-07-28
K821328	C.a.p.d. Automatic Heater #Pdc 2000 Hcp	Medionics International, Inc.	KPF	Class II	1982-07-28
K822079	Enzymatic CO2	American Monitor Corp.	KHS	Class II	1982-07-27
K822078	Dade Disp. Dispensing-Spreading Pipets	American Dade	JRC	Class I	1982-07-27
K822067	Emit C-Reactive Protein Autocarousel	Syva Co.	DCK	Class II	1982-07-27
K822053	Zetaphase-Dig	Biological & Diagnostic Products	DON	Class II	1982-07-27
K822052	Emit D.a.v. Methaqualone Urine Calibra	Syva Co.	DLJ	Class II	1982-07-27
K822051	Emit D.a.v. Methaqualone Assay	Syva Co.	KXS	Class II	1982-07-27
K821963	Eia-F8 Enzymeimmunoassay Kit for Quant.	Intl. Immunoassay Laboratories, Inc.	GGP	Class II	1982-07-27
K821919	Powdered Rpmi-1634 Medium	Dutchland Laboratories, Inc.	KIT	Class I	1982-07-27
K821918	Powdered Rpmi-1603 Medium	Dutchland Laboratories, Inc.	KIT	Class I	1982-07-27
K821917	Waymouth's Powder Medium	Dutchland Laboratories, Inc.	KIT	Class I	1982-07-27
K821916	Improved Mem-Richter's Powder Modif.	Dutchland Laboratories, Inc.	KIT	Class I	1982-07-27
K821915	Bme Autoclavable Medium	Dutchland Laboratories, Inc.	KIT	Class I	1982-07-27
K821914	Coon's F-12 Powder Medium	Dutchland Laboratories, Inc.	KIT	Class I	1982-07-27
K821913	Iscove's Modified Dulbecco Powder Medium	Dutchland Laboratories, Inc.	KIT	Class I	1982-07-27
K821912	Mccoy's Powder Medium 5A Suspension	Dutchland Laboratories, Inc.	KIT	Class I	1982-07-27
K821911	S-Mem-Joklik's Powder	Dutchland Laboratories, Inc.	KIT	Class I	1982-07-27
K822103	Model M3000xa Ventilator Specifica	Thompson Respiration Products, Inc.	CBK	Class II	1982-07-26
K822031	Autorange Model 205	Tri W-G, Inc.	BXB	Class I	1982-07-26
K822022	Sport Supports	Ginny, Inc.	IQI	Class I	1982-07-26
K821904	Xomed Mandibular Tray	Xomed, Inc.	JAZ	Class II	1982-07-26
K821712	Informed Remote Field Unit Model Ifm1000	Burditt & Calkins-Siemens-Elema	BTY	Class II	1982-07-26
K821568	Blow-Singer Tracheostoma Valve	Bivona Medical Technologies	EWL	Class II	1982-07-26
K821478	Telephone Link Data Transmission Sys	Advantage Medical Systems, Inc.	HGM	Class II	1982-07-26
K821265	Pneumopulssor (Pps II)	Strom Corp.	BYI	Class II	1982-07-26
K821809	Thermofonte Air Message Bath	Greenfields	ILJ	Class II	1982-07-23
K827666	Suntanning Booth	Carribean Connection			1982-07-22
K827644	Deltascan Hps CT Scanner	Technicare Corp.			1982-07-22
K827607	Model 712 Micromanipulator	Laser Industries, Ltd.			1982-07-22
K827035	Ocular Biometer 4000	Radionics Medical, Inc.			1982-07-22
K822059	Show'rbag	The Healthcare Group Laboratories, Inc.	LGF	Class I	1982-07-22
K822048	H-H Nerve Root Retractor	Holter-Hausner Intl.	HAO	Class I	1982-07-22
K822024	Bacillu S Subtilis Biological Indica.	Findley Research, Inc.	FRC	Class II	1982-07-22
K821984	Quantimetric 2 C-Reactive Protein Reag.	Kallestad Laboratories, Inc.	DCK	Class II	1982-07-22
K821981	Titan Gel Cpk/ldh Isoenzyme Control	Helena Laboratories, Corp.	JJT	Class I	1982-07-22
K821977	Gramstain Set	Granite Diagnostics, Inc.	HYI	Class I	1982-07-22
K821964	125I Quick-Mb Test Kit for Quantitation	Intl. Immunoassay Laboratories, Inc.	JHT	Class II	1982-07-22
K821961	96 Well Dispenser	Skatron, Inc.	JTC	Class I	1982-07-22
K821944	Tandem Hcg Immunoezymetric Assay Kit	Hybritech, Inc.	JHI	Class II	1982-07-22
K821931	Zeta-Cort	Amf Biological and Diagnostics Co.	CGR	Class II	1982-07-22
K821907	Neident*	Analytical Products, Inc.	JTO	Class I	1982-07-22
K821854	U-200 Bag	Medical Technologies of Georgia	KNX	Class II	1982-07-22
K821853	U-100 Bag	Medical Technologies of Georgia	KNX	Class II	1982-07-22
K821847	I.m. Arthroscope	Instrument Makar, Inc.	HRX	Class II	1982-07-22
K821830	Mi Das 1000 Automatic Slide Stainer	Innovative Medical Systems, Inc.	KPA	Class I	1982-07-22
K821701	Rapido-Lastic in Sterile Form	Conco Medical Co.	EFQ	Unclassified	1982-07-22
K821694	Arthrolux Arthroscope	Arthro-Tech, Inc.	HRX	Class II	1982-07-22
K821672	Proflex	Utah Medical Products, Inc	HRX	Class II	1982-07-22
K821449	P6s Athletic	Squire, Sanders & Dempsey	IPF	Class II	1982-07-22