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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2868 of 3529

510(k) clearances, page 2868 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K861698	Visiscan CT Scanners - Models V600, V1200 & V2400	Visiscan	JAK	Class II	1986-10-03
K861688	Xanar CO2 Surgical Laser System Model Xap-15	Xanar, Inc.	GEX	Class II	1986-10-03
K861263	Behring Rapimat II	Behring Diagnostics, Inc.	JJQ	Class I	1986-10-03
K861255	Behring Rapignost Total Screen L Urine Test Strips	Behring Diagnostics, Inc.	JIL	Class II	1986-10-03
K863697	Modified Silicone Dual Lumen Subclavian Cannula	Shiley, Inc.	LFJ	Class II	1986-10-02
K863676	Genteel	Luben Dental Co., Inc.	ELC	Class II	1986-10-02
K863627	Micro Surgical Drill System	Acumed Instruments Corp.			1986-10-02
K863598	Video Camera System	American Edwards Laboratories	FWF	Class I	1986-10-02
K863563	Uresil Radiopaque Silicone Bands	Uresil, LLC			1986-10-02
K863555	Bremi Beauty Bronze	Handelsonderneming Bremi B.V.	FTC	Class II	1986-10-02
K863550	Potassium Hydroxide 10% W/v	Reagent Laboratory, Inc.	PPM	Class I	1986-10-02
K863518	Weingart Model 1000 Sunlamp Product	Weingart, Inc.	FTC	Class II	1986-10-02
K863471	Colorado Medical Model Ptc 1000	Colorado Medical, Inc.	KXM	Class II	1986-10-02
K863464	Tampax Super Tampons	Tambrands Inc.	HEB	Class II	1986-10-02
K863413	Bipolforceps	Treace Medical, Inc.	GEI	Class II	1986-10-02
K863412	Bipol Cable	Treace Medical, Inc.	GEI	Class II	1986-10-02
K863376	Model Mc-1 Surgical Video Camera	Biometric Products, Inc.	FWF	Class I	1986-10-02
K863330	Disposable Pneumoperitoneum Needle	United States Surgical, A Division of Tyco Healthc	FHO	Class II	1986-10-02
K863261	Creatinine Procedure	Data Medical Associates, Inc.	CGX	Class II	1986-10-02
K863205	Swivel Coupler	Venmill Swivel, Co.	BYJ	Class II	1986-10-02
K862422	Model 20-B CO2 Laser for General & Plastic Surgery	Directed Energy, Inc.	GEX	Class II	1986-10-02
K861599	T-Fastener	Medi-Tech, Inc.	KNT	Class II	1986-10-02
K860831	Model Ls-870 CO2 Surgical Laser System (Modified)	Cooper Lasersonics, Inc.	GEX	Class II	1986-10-02
K863487	Quantimune(r) Ferritin Irma	Bio-Rad	DBF	Class II	1986-10-01
K863425	Amresco Flow Pac Urea Nitrogen Reagents #1346	American Research Products Co.	CDW	Class II	1986-10-01
K863123	Immuno Biotech Mugwart Allergen Disc	Immuno Nuclear Corp.	DHB	Class II	1986-10-01
K863021	Cm-II, Cm-I Water Unit	Sds Dental, Inc.	EIA	Class I	1986-10-01
K863016	Dentatus L Set	Sds Dental, Inc.	KLC	Class I	1986-10-01
K863015	Isoprat C-III Set/isocart III Auxiliary Unit	Sds Dental, Inc.			1986-10-01
K863014	Isoprat F-III Set/isolax Chair	Sds Dental, Inc.			1986-10-01
K863013	Isolax Pedal Set	Sds Dental, Inc.			1986-10-01
K863012	Minilax Set	Sds Dental, Inc.			1986-10-01
K863007	Euroflex F-IV, Isoflex III	Sds Dental, Inc.			1986-10-01
K862973	Stockert-Shiley Caps Timer Module	Shiley, Inc.	DTQ	Class II	1986-10-01
K862705	Cytomegalovirus Igg Eia Test Kit	Labsystems, Inc.	GQI	Class II	1986-10-01
K862117	Tracker Infusion Catheter	Target Therapeutics	DQY	Class II	1986-10-01
K860638	Novemperc Double Lumen Intra-Aortic Balloon	Kontron Instruments, Inc.	DSP	Class II	1986-10-01
K863603	Gi Motility Test Medium W/ttc	BD Becton Dickinson Vacutainer Systems Preanalytic	JSS	Class I	1986-09-30
K863602	Buffered Glycerol Saline	BD Becton Dickinson Vacutainer Systems Preanalytic	JSM	Class I	1986-09-30
K863601	Onpg Solution	BD Becton Dickinson Vacutainer Systems Preanalytic	JTO	Class I	1986-09-30
K863600	Motility Indole Lysine Sulfide (Mils) Medium	BD Becton Dickinson Vacutainer Systems Preanalytic	JSH	Class I	1986-09-30
K863599	Starch Agar W/brom Cresol Purple	BD Becton Dickinson Vacutainer Systems Preanalytic	JSH	Class I	1986-09-30
K863573	Bird Seed Agar	BD Becton Dickinson Vacutainer Systems Preanalytic	JSH	Class I	1986-09-30
K863572	Xanthine/tyrosine/casein Agar	BD Becton Dickinson Vacutainer Systems Preanalytic	JSH	Class I	1986-09-30
K863549	Reusable/disposable Autopsy Knife Set	Surgipath Medical Industries, Inc.	EMF	Class I	1986-09-30
K863516	Electronic Metal Locator Model Md-1	Advanced Instruments, LLC			1986-09-30
K863512	Drape Stericover	STERIMED, Inc.	KKX	Class II	1986-09-30
K863390	Hydrocolloid Dressings - Sterile	Convatec, A Division of E.R. Squibb & Sons	FRO	Unclassified	1986-09-30
K863194	Tenderm Tape	Lectec Corp.			1986-09-30
K863038	Gram Positive Fluorescent Identification Panel	American Micro Scan	LQL	Class I	1986-09-30