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 2695 of 3530

510(k) clearances, page 2695 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K882893	Condoms (Ramses, Sheik and Koromex)	Schmid Laboratories, Inc.	HIS	Class II	1988-10-26
K881843	Pediatric Hospital Bed	Medical Group	IOQ	Class II	1988-10-26
K884208	Listeria Selective Medium (Oxford Formulation)	Oxoid U.S.A., Inc.	KZI	Class I	1988-10-25
K884069	Snap N' Stain Iodine Stain	Scientific Device Laboratory, Inc.	JTS	Class I	1988-10-25
K884061	Add-a-Cath	Femcare Ltd.	KOB	Class II	1988-10-25
K883975	Disp. 20 Gauge Site Fiber Optic Cable & Illumi.	Site Microsurgical Systems, Inc.	HQE	Class II	1988-10-25
K883971	Qlia T Uptake Assay	BD Becton Dickinson Vacutainer Systems Preanalytic	CEC	Class II	1988-10-25
K883830	Fiber Optic Laryngoscope	Effner, Inc.	CCW	Class I	1988-10-25
K883778	Rubella Igm Microassay	Diamedix Corp.	LFX	Class II	1988-10-25
K883658	I-Spose Eye Shield	Products for Medicine	FXX	Class II	1988-10-25
K883605	Modified Reusable Site Fiber Optic Cable	Site Microsurgical Systems, Inc.	HQE	Class II	1988-10-25
K883560	Cdt Cytotoxi Test	Advanced Clinical Diagnostics	LLH	Class I	1988-10-25
K883525	Oxalate Reagent	Sigma Chemical Co.	LPW	Class I	1988-10-25
K883489	Kratz Nova Sert(tm)	Coopervision-Cilco	KYB	Class I	1988-10-25
K883479	Stratus Total Triiodothyronine T3 Fluoro. Enzyme	Baxter Healthcare Corporation	CDP	Class II	1988-10-25
K883453	Roche Reagent for Calcium	Roche Diagnostic Systems, Inc.	CJY	Class II	1988-10-25
K883403	Denta Plus	Connoisseurs Products Corp.	JER	Class I	1988-10-25
K883390	Pmd System-20	Datatek, Inc.	KMI	Class I	1988-10-25
K883321	Clinistat Dry Chem Analyzer/uric Acid Reagent Test	Kulzer GmbH	JJE	Class I	1988-10-25
K883266	Fdl Elisa for Chlamydia	Fairleigh Dickinson Laboratories, Inc.	LJC	Class I	1988-10-25
K883173	Model 27084 Uromat for Urological Irrigation	Karl Storz Endoscopy-America, Inc.	OCX	Class II	1988-10-25
K883104	Chem 1 Uibc (Iron Binding Capacity Test)	Technicon Instruments Corp.	JMO	Class I	1988-10-25
K883083	Mycoplasma Pneumoniae Antibody Latex Test System	Medical Diagnostic Technologies, Inc.	GSA	Class I	1988-10-25
K882811	Strepslide	Ncs Diagnostics, Inc.	GTY	Class I	1988-10-25
K882486	Lyphochek Unassayed Chem. Control (Human) I and II	Bio-Rad	JJY	Class I	1988-10-25
K882428	Redy 2000	bioMerieux, Inc.	FKT	Class II	1988-10-25
K882232	Discover(r)	Carter Products	LCX	Class II	1988-10-25
K882059	Bilirubin Standard	Verichem Laboratories, Inc.	JIT	Class II	1988-10-25
K881264	Perma Pure Nafion Tube Dryer-Model Me	Perma Pure Products, Inc.	CBQ	Class II	1988-10-25
K881079	Uvp Volumed 2001	Ferguson Medical	FRN	Class II	1988-10-25
K884195	General Surgical Instruments (Various Types)	Mumtaz I. Malik	GEN	Class I	1988-10-24
K884175	#820/821 Bipolar Forceps	Olsen Electrosurgical, Inc.	HAM	Class II	1988-10-24
K884174	Modified Olsen 755/756 Switchpens	Olsen Electrosurgical, Inc.	HAM	Class II	1988-10-24
K884173	#920 Disposable Tur Cable	Olsen Electrosurgical, Inc.	HAM	Class II	1988-10-24
K884172	Modified Olsen #770 Disposable Holster	Olsen Electrosurgical, Inc.	HAM	Class II	1988-10-24
K884171	#875 Disposable Biopolar Cable	Olsen Electrosurgical, Inc.	HAM	Class II	1988-10-24
K883198	Biovec Biomechanic Force Analysis System	Advanced Mechanical Technology Inc	KHX	Class I	1988-10-24
K883131	Biomechanics Force Platform #Lg6-4-1000 & 2000	Advanced Mechanical Technology Inc	KHX	Class I	1988-10-24
K883130	Biomechanics Force Platform/# Or6-5-1000 & 2000	Advanced Mechanical Technology Inc	KHX	Class I	1988-10-24
K883129	Biomechanics Force Platform/#or 6-6-1000 & 2000	Advanced Mechanical Technology Inc	KHX	Class I	1988-10-24
K884149	Comfort Strap	Comfort Strap Co.	CAT	Class I	1988-10-21
K884134	Micro-X 100Cp	Fischer Imaging Corp.	IZO	Class I	1988-10-21
K884080	Modified Fef(tm) End-Tidal CO2 Detector	Fenem, Inc.	CCK	Class II	1988-10-21
K883863	Genesis 180	Fischer Imaging Corp.	IXR	Class II	1988-10-21
K883802	Caretex Central Supply Wrap	James River Corp.	FRG	Class II	1988-10-21
K883766	Mouth-to-Mask Ventilatory Adjunct	Medic One	KGB	Class I	1988-10-21
K883644	Capillary Flow Dialyzers Models Ht. 130 & 170	Baxter Healthcare Corporation	FJI	Class II	1988-10-21
K883534	Capillary Flow Dialyzers Models Ht.80 & Ht.100	Baxter Healthcare Corporation	FJI	Class II	1988-10-21
K883318	Valleylab i.v. Administration Sets	Medtronic, Inc.	FPA	Class II	1988-10-21
K883239	Capd Ultraviolet(u.v.) Germicidal Exchange Dev Sys	Baxter Healthcare Corporation	KDJ	Class II	1988-10-21