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 2026-10-12, 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 3250 of 3528

510(k) clearances, page 3250 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K812750	Il 703, Stat Separator	Instrumentation Laboratory Co.	JRL	Class I	1982-01-26
K820081	Eska Jonas Silicone-Silver Penile Prost	Dacomed Corp.	FAE	Class II	1982-01-25
K820073	Open Loop Ambulatory Insulin Infusion	Cardiac Pacemakers, Inc.	FRN	Class II	1982-01-25
K820047	Spinocan Spinal Needle	Burron Medical Products, Inc.	BSP	Class II	1982-01-25
K813647	Pbc Syringe	Philadelphia Biologics Center	FMF	Class II	1982-01-25
K813642	Petal Soft Plastic Applicator Tampax	Tampax, Inc.	HEB	Class II	1982-01-25
K813408	Sage 2200 Sterile Specimen Container	Sage Products LLC	FMT	Class II	1982-01-25
K812776	Transducer Antiseptic Towelette	Echo Laboratories, Inc.	ITX	Class II	1982-01-25
K812678	Tegaderm Transparent Dressing	3M Company	FRO	Unclassified	1982-01-25
K810185	Irrigation Syringe	Karoco Intl.	FQH	Class II	1982-01-25
K820041	Bosch Top Star III	Bosch Hearing Instruments, Inc.	ESD	Class I	1982-01-22
K820039	Leeco Prl-Quant Diagnostic Test Kit	Leeco Diagnostics, Inc.	CFT	Class I	1982-01-22
K820036	Cxd 400	Cdx Corp.	BZG	Class II	1982-01-22
K820033	Cardiovue Accessory Cart	Diasonics, Inc.	DSF	Class I	1982-01-22
K820020	Spryce, Denture Cleanser	Richardson-Vicks, Inc.	EFT	Class I	1982-01-22
K820011	Cardiostress	Instruments for Cardiac Research	DPS	Class II	1982-01-22
K820009	Arrow Jugular Puncture Kit 16 Ga.	Arrow Intl., Inc.	DQY	Class II	1982-01-22
K820006	Zeon Composite Resin System	National Patent Development Corp.	EBF	Class II	1982-01-22
K820005	Total Hemolytic Complement Test Kit	Meloy Laboratories, Inc.			1982-01-22
K813645	Micromedic Htsh Ria Kit	Micromedic Systems	JLW	Class II	1982-01-22
K813639	Series 400 Disposable Temperature Probe	Yellow Springs Instrument Co., Inc.	FLL	Class II	1982-01-22
K813624	Advanced Catheter Systems Coronary Guid	Advanced Catheter Systems	DQO	Class II	1982-01-22
K813623	Simpson-Robert Coronary Guiding Cathet	Advanced Catheter Systems	DQO	Class II	1982-01-22
K813622	Indeflator	Advanced Catheter Systems	DQO	Class II	1982-01-22
K813616	Tekna Med Myringotomy Dispos-Oto Kit	Humboldt Products	ETD	Class II	1982-01-22
K813608	Potassium Reagent Set	Diagnostic Specialties	CEJ	Class II	1982-01-22
K813600	Aufranc-Turner Type Acetabular Compon	Intermedics Orthopedics	JDI	Class II	1982-01-22
K813599	101-32 Femoral Component	Intermedics Orthopedics	JDL	Class III	1982-01-22
K813597	Tdx Primidone	Abbott Medical	DJD	Class II	1982-01-22
K813576	Siemens-Elema Pulse Generator 659	Siemens Elema AB	DXY	Class III	1982-01-22
K813565	Radiation Sterilized Surgeon's Gloves	Travenol Laboratories, S.A.	KGO	Class I	1982-01-22
K813556	Mod. 587 Blood Pressure & Pulse Monitor	Bio Mega Diagnostic, Inc.	DXN	Class II	1982-01-22
K813534	Command P5	Cardiac Pacemakers, Inc.	DXY	Class III	1982-01-22
K813492	Britt Krypton Lasers 150K & 152K	Britt Corp., Inc.	HQF	Class II	1982-01-22
K813483	Oms Anterior Chamber Infusion Needle	Optical Micro Systems, Inc.			1982-01-22
K813481	Oms Infusion Cannula Assemble	Optical Micro Systems, Inc.	HMX	Class I	1982-01-22
K813473	5B Slave Module Syringe Pump	Baxter Healthcare Corporation	FRN	Class II	1982-01-22
K813450	Boundary Single-Use Drapes	The Buckeye Cellulose Corp.	KKX	Class II	1982-01-22
K813439	Rtp-5000	Philips North America LLC	JAD	Class II	1982-01-22
K813429	Laser Photocoagulator Argon Med. Laser	American Laser Corp.	HPJ	Class II	1982-01-22
K813419	Comfort Cushion Dry Burn Pad III	American Convertors Div., American Pharmaseal	NAB	Class I	1982-01-22
K813399	Erg-Jet Electrode	Nicolet Biomedical Instruments	HLZ	Class II	1982-01-22
K813394	Ds-7 Closed Wound Suction Drain System	Cox-Uphuff Intl.	GCX	Class II	1982-01-22
K813382	Disposable Adult Anes. Circuit	Intec.	CAI	Class I	1982-01-22
K813379	Radionuclide Dose Calibrator	Medi Nuclear Corp., Inc.	KPT	Class II	1982-01-22
K813303	Conphar, Wall Aneroid Sphygmomanometer	Conphar, Inc.	DXQ	Class II	1982-01-22
K813302	Conphar Palm Aneroid Sphygmomanometer	Conphar, Inc.	DXQ	Class II	1982-01-22
K813297	Conphar Laryngoscope	Conphar, Inc.	EQN	Class II	1982-01-22
K813286	Pre-Pack TENS	Cunningham Woodland, Inc.	GDY	Class I	1982-01-22
K813238	Neocare Baby-Controlled Incubator	Vickers America Medical Corp.	FMZ	Class II	1982-01-22