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 3108 of 3528

510(k) clearances, page 3108 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K833730	Non Adherent Bandage/sheet	American Medical Disposable, Inc.	FRO	Unclassified	1984-01-27
K833695	Adult Monitoring Elector@@rode 9431-300	Marquette Electronics, Inc.	DRX	Class II	1984-01-27
K833652	Yasargil Fenestrated Aneurysm Clip &	Advanced Biosearch Assn.	HCH	Class II	1984-01-27
K833619	Conductance Meter	Circadian, Inc.	KRC	Class II	1984-01-27
K833590	Dress, Surgical Adhesive	Lectec Corp.	KGX	Class I	1984-01-27
K833552	Trend Processor Option for #515 Neonat	GE Medical Systems Information Technologies, Inc.	DRT	Class II	1984-01-27
K833527	UV-a Sun Tanning Equipment	Tan America Mfg.	FTC	Class II	1984-01-27
K833511	UV-a Suntanning Equipment-Silgmann	Thomas G. Mason	FTC	Class II	1984-01-27
K833490	Silgmann Solariums-Type 1218 Canopy &	Life Image, Inc.	FTC	Class II	1984-01-27
K833467	Sure-Cut	Diverse Technologies, Inc.	GDX	Class I	1984-01-27
K833464	Porocoat Schatzker Acetabulum	Depuy, Inc.	LPH	Class II	1984-01-27
K833355	Sdc Vascular Ties	Science Development Corp.	KDC	Class I	1984-01-27
K833350	Kosmedico Gmbh Sun Lamp	Kosmedico, Kosmetische & Medizinisch	FTC	Class II	1984-01-27
K833240	Int'l Tanning Systems B.v	Business Contacts USA	FTC	Class II	1984-01-27
K833229	Sun Bed by Verre Et Quartz Uva-France	H & M Douglas Enterprises, Inc.	FTZ	Class I	1984-01-27
K833126	Dressing Change Trays	Intermed, Inc.			1984-01-27
K833081	Absorable Polyglactin 910-Anastomotic	Ethicon, Inc			1984-01-27
K833078	Hollow Fiber Membrane Oxygenator-Hf4000	Cordis US Corp.	DTZ	Class II	1984-01-27
K833075	Wet Dressing Kit	Clinipad Corp.	KDD	Class I	1984-01-27
K832794	Suntanning Booths and Beds	Tan-N-Trim	FTC	Class II	1984-01-27
K832765	Flexi-Ty	BD Becton Dickinson Vacutainer Systems Preanalytic	GAD	Class I	1984-01-27
K832764	Alpha Non-Invasive Bp Cardule	Spacelabs, Inc.	DXN	Class II	1984-01-27
K832644	Alpha Cardiac Output Cardule #1899	Spacelabs, Inc.	DXG	Class II	1984-01-27
K832448	Triflex Surgeon's Gloves	Travenol Laboratories, S.A.	KGO	Class I	1984-01-27
K832354	Holta-Med Informer Playback	Holta-Med	DSI	Class II	1984-01-27
K831763	Max I	Trade Max, Inc.	DQD	Class II	1984-01-27
K833758	P.t.i. Dressing Change Trays	Packaging Technologies, Inc.	FMC	Class I	1984-01-26
K833581	Modif. of Emit Urine Opiate Assay	Syva Co.	DJG	Class II	1984-01-26
K833580	Modif. of Emit Urine Cannabinoid	Syva Co.	LDJ	Class II	1984-01-26
K833579	Modif. of Emit Urine Amphetamine	Syva Co.	DKZ	Class II	1984-01-26
K833578	Modif. of Emit Urine Benzodiazepine	Syva Co.	JXM	Class II	1984-01-26
K833577	Modif. of Emit Urine Barbiturate	Syva Co.	DIS	Class II	1984-01-26
K833547	Rotary Vascular Knife	Formedco, Inc.	DWS	Class I	1984-01-26
K833325	Ambulase Xam-15 Xanar Surg. Laser	Xanar, Inc.			1984-01-26
K833155	Rayden Medical Mini Pulse Volume Record	Burditt & Calkins-Siemens-Elema	DSB	Class II	1984-01-26
K834536	Crystalcone Face Mask-Med-W/hookring	Warne Surgical Products, Ltd.	BSJ	Class I	1984-01-25
K834532	Sterile Wet Dressing Pack	W.G. Whitney Corp.	KDD	Class I	1984-01-25
K834482	Tissue Mimicking Ultrasound Phantoms	Radiation Measurements, Inc.	IXF	Class I	1984-01-25
K834481	Doppler Phantom Flow Control Sys	Radiation Measurements, Inc.	IXF	Class I	1984-01-25
K834154	Flo-Gard 8000 Computer Control Infusi	Travenol Laboratories, S.A.	LDR	Class II	1984-01-25
K834071	Lymphangiography Set Special 30G	Hyperion, Inc.	FPA	Class II	1984-01-25
K833966	Pump Infusion Wearable Infusion Pump	Oximetrix, Inc.	JSJ	Class I	1984-01-25
K833944	Sterile Solution Warmer	National Fabtronix, Inc.	LHC	Class I	1984-01-25
K833877	Single-Use Surgical Drapes	Procter & Gamble Mfg. Co.	KKX	Class II	1984-01-25
K833719	Prepacell Thin Needle Aspiration Tray	Applied Medical Devices, Inc.	KOD	Class II	1984-01-25
K833698	Amer. V. Mueller Surg. Staples Ila	American Heyer Schulte	GDW	Class II	1984-01-25
K833674	Accurate Measurement Device Kg-Amd	Sorensen Research	GCX	Class II	1984-01-25
K833258	Skin Tech. Surgi-Strips	Lee Tec Corp.	FPX	Class I	1984-01-25
K833122	Burlington Antimicrobial Stockineette	Balfour, Inc.	KKX	Class II	1984-01-25
K833121	Burlington Sterile Antimicrobial Stock	Balfour, Inc.	KKX	Class II	1984-01-25