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 3130 of 3528

510(k) clearances, page 3130 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K832974	Maxithins Unscented Panty Shields	Tampax, Inc.	HHD	Class I	1983-10-14
K832956	Ceftizolime 30 Mcg Sensi-Disc	BD Becton Dickinson Vacutainer Systems Preanalytic	JTN	Class II	1983-10-14
K832946	Dale Endotracheal Tube Holder	Dale Medical Products, Inc.	JAY	Class I	1983-10-14
K832937	Shaban #9868 Tubing Kit-9870 Stylet	Shaban Mfg. Co.	JJO	Class I	1983-10-14
K832936	Shaban #9850 Pump Windings-9860 Filter	Shaban Mfg. Co.	JJO	Class I	1983-10-14
K832932	Shaban #9858 Aspirator Assemble #9862-	Shaban Mfg. Co.	JJO	Class I	1983-10-14
K832931	Shaban #9852 Chimney-#9854 Screen &	Shaban Mfg. Co.	JJO	Class I	1983-10-14
K832927	Gravity Enteral Feeding Set	Medical Connections	KNT	Class II	1983-10-14
K832915	Urethral Obstruct Primary Exchange Sten	Surgitek	FAD	Class II	1983-10-14
K832909	Cefuroxime 30Mcg. Sensitivity Discs	Difco Laboratories, Inc.	JTN	Class II	1983-10-14
K832899	Zimmer Ossimeter	Zimmer GmbH	FTY	Class I	1983-10-14
K832896	Legionella Indirect Fluorescent Antibod	Biodan Medical Systems, Ltd.	LHL	Class II	1983-10-14
K832894	Lundia 10-2-L Parallel Plate Hemodialy	Gambro, Inc.	KOC	Class II	1983-10-14
K832878	Goal Tender	Dna Medical, Inc.	BWF	Class II	1983-10-14
K832872	Hexokinase, Glucose	Horiba Instruments Incorporated	CFR	Class II	1983-10-14
K832871	Lipase Hydrolysis/glycerol Kinase	Horiba Instruments Incorporated	CDT	Class I	1983-10-14
K832823	Enzymune-Test Tsh	Icl Scientific	JLW	Class II	1983-10-14
K832822	Closed Sys. Drainage Bags & Trays	MEDLINE INDUSTRIES, LP - Northfield	KNX	Class II	1983-10-14
K832821	Fiax Igg Test	Intl. Diagnostic Technology	DFI	Class I	1983-10-14
K832808	Ureteral Dilation Set	Van-Tec, Inc.	EZN	Class II	1983-10-14
K832799	Modifica- of Emit Cad Lidocaine Assay	Syva Co.	KLR	Class II	1983-10-14
K832798	Modifica-of Emit AED Primidone Assay	Syva Co.	DJD	Class II	1983-10-14
K832791	Serayzer Alt/sgpt Reagent Strips	Miles Laboratories, Inc.	CKC	Class I	1983-10-14
K832790	Seralyzer Ast/sgot Reagent Strips	Miles Laboratories, Inc.	CIF	Class II	1983-10-14
K832785	Compur* Easy Touch Uric Acid Reagent	Worthington Diagnostic Systems	KNK	Class I	1983-10-14
K832780	Flow-Pac Sholesterol Reagent Set	American Research Products Co.	CHH	Class I	1983-10-14
K832779	Referee Blood Gas Analyzer-Electrodes	Analytical Products, Inc.	CHL	Class II	1983-10-14
K832760	Ria Software	Kemble Instruments, Inc.	JQP	Class I	1983-10-14
K832759	Total Iron-Binding Capacity Accesory	Seragen Diagnostics, Inc.	JMO	Class I	1983-10-14
K832749	Easytouch Bun Reagent Set	Worthington Diagnostic Systems	CDQ	Class II	1983-10-14
K832748	Compur* Easytouch Total Bilirubin	Worthington Diagnostic Systems	CIG	Class II	1983-10-14
K832747	Albumin Reagent Set	Biorent Diagnostic, Inc.	CIX	Class II	1983-10-14
K832734	Kemtek 400 Ria Gamma Counter	Kemble Instruments, Inc.	JJJ	Class I	1983-10-14
K832708	Paramax Calcium Reagent-Glutamy-Trans	American Dade	CIC	Class II	1983-10-14
K832686	Multiple Manual Surgical Instruments	Hirata Sangyo Co. USA, Inc.	HTO	Class I	1983-10-14
K832680	Micro-Edge Disposable Blades	Micromedics, Inc.	KDC	Class I	1983-10-14
K832666	Nephross Presto	bioMerieux, Inc.	KOC	Class II	1983-10-14
K832653	Cefuroxime 30Mcg. Suscep Disk	General Diagnostics	JTN	Class II	1983-10-14
K832636	Frazier Suction Instrument-Dispos	Pilling Co.	GEA	Class I	1983-10-14
K832626	Top Sterile Dispos. Hypodermic Needles	Top Surgical Manufacturers Co.	GAA	Class I	1983-10-14
K832623	Top Dispos. Infusion Set/hemodialy	Top Surgical Manufacturers Co.	KOC	Class II	1983-10-14
K832622	Winged Infusion Set	Top Surgical Manufacturers Co.	FPA	Class II	1983-10-14
K832621	Top Disposable Plastic Syringes	Top Surgical Manufacturers Co.	FMF	Class II	1983-10-14
K832590	Mouth-to-Mouth Shield Applicator	Mem, Inc.	LAE	Class II	1983-10-14
K832546	Mark V High Voltage Galvanic Stimulatorr	Orthion Corp.	IPF	Class II	1983-10-14
K832517	Custom Kwik Set And/or Pak	Norton Texas Medical Products	JOL	Class II	1983-10-14
K832515	Cefuroxime 30 Mcg Sensi-Disc	BD Becton Dickinson Vacutainer Systems Preanalytic	JTN	Class II	1983-10-14
K832498	Percutaneous Tracheostomy Device	Frederic J. Toye, M.D.	BTO	Class II	1983-10-14
K832450	Uro-Tex Male External Catheter	Sierra Laboratories, Inc.	KNX	Class II	1983-10-14
K832427	Easytouch Tromboplastin Reagent	Worthington Diagnostic Systems	GJS	Class II	1983-10-14