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 3113 of 3528

510(k) clearances, page 3113 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K834025	Sarns Cardioplegia Cannula Y	3M Health Care, Sarns	DWF	Class II	1984-01-03
K834010	Dermatophyte Test Medium	Micro Media Laboratories	JSJ	Class I	1984-01-03
K834006	Brucella Media	Micro Media Laboratories	JSG	Class I	1984-01-03
K834005	Selective Streptococcus Agar	Micro Media Laboratories	JSJ	Class I	1984-01-03
K833955	Novel Dispenser/package	Dentsply Intl.	EIY	Class I	1984-01-03
K833937	Umi Percutaneous Transhepatic Cholan	Universal Medical Instrument Corp.	FGE	Class II	1984-01-03
K833906	Negative Pressure Venous Blood Line	Erika, Inc.	KOC	Class II	1984-01-03
K833905	Negative Pressure Arterial Blood	Erika, Inc.	KOC	Class II	1984-01-03
K833896	Bicarbolyte Hemo-Dial	Edlaw Pharmaceuticals, Inc.	KOC	Class II	1984-01-03
K833888	Penase	Oxoid U.S.A., Inc.	MDB	Class I	1984-01-03
K833859	Tamponade Balloon Cuff	American Endoscopy, Inc.	GCP	Class II	1984-01-03
K833805	Glycoglobin Kit	Endocrine Sciences Products	LCP	Class II	1984-01-03
K833670	Bos-Cm40,50 Holder & Reservoir Bag	American Bentley	DTZ	Class II	1984-01-03
K833607	Mcgee Forceps	Microtek Medical LLC	KAE	Class I	1984-01-03
K833606	Implant Measuring Gauge	Microtek Medical LLC	JYJ	Class I	1984-01-03
K833605	Cupped Forceps	Microtek Medical LLC	KAE	Class I	1984-01-03
K833604	Adjustable Fork Retractor	Microtek Medical LLC	KAL	Class I	1984-01-03
K833603	Scissors Shea Bellucc	Microtek Medical LLC	JZB	Class I	1984-01-03
K833602	Roller Knife-Transverse -Sagittal	Microtek Medical LLC	JYO	Class I	1984-01-03
K833601	Antrum & Attic Mirror	Microtek Medical LLC	KAI	Class I	1984-01-03
K833563	Hc Plus	Coulter Electronics, Inc.	JPK	Class II	1984-01-03
K833559	Armboard	Mtd, Inc.	KPR	Class II	1984-01-03
K833318	Normal Goat Serum	Biosan Laboratories, Inc.	DHX	Class II	1984-01-03
K833290	C & B 40 Pentro C & B40	Genesis Industries, Inc.	EIS	Class I	1984-01-03
K833287	Satin Cast Econocast	Genesis Industries, Inc.	EIS	Class I	1984-01-03
K833261	Interim Temp. Crown & Bridge Resin	Coe Laboratories, Inc.	EBG	Class II	1984-01-03
K833179	O.b. Tampons	Personal Products Co.	HEB	Class II	1984-01-03
K833006	Cephalometer & Fixator	Modern Systems, Inc.	EAG	Class II	1984-01-03
K832960	Shuffield Tech Enema Tip	Shuffield Tech Co.	FCE	Class I	1984-01-03
K832774	Repair Kits for Right Atrial Cath	Quinton, Inc.	LJS	Class II	1984-01-03
K832679	Non-Invasive Clinical Vascular Lab	Life Sciences Manufacturing, Inc.	DQC	Class I	1984-01-03
K832580	Raaf Catheter Repair Kit	Quinton, Inc.	LJS	Class II	1984-01-03
K832547	Ultrafiltration Controller	Extracorporeal Medical Specialities, Inc.	KDI	Class II	1984-01-03
K832540	Drumto Stapes Prosthesis	Humboldt Products	ETB	Class II	1984-01-03
K832092	Electrocardiograph Machines, W/analyz	Fukuda Denshi USA, Inc.			1984-01-03
K831710	Bard Absorption Dressing	C.R. Bard Inc	FRO	Unclassified	1984-01-03
K831703	Coverups	The Urology Group	NAD	Class I	1984-01-03
K831530	Plastic Leg Bag	Forever-Dry, Inc.	KNX	Class II	1984-01-03
K831423	Therapeutic Exchange System	Extracorporeal Medical Specialities, Inc.	LQQ	Class III	1984-01-03
K833276	Drug Standards	Supelco, Inc.	DKB	Class II	1984-01-01
K834029	Bio-Urea	Remel Co.	JTO	Class I	1983-12-30
K834028	Bio-Ornithine	Remel Co.	JTO	Class I	1983-12-30
K834022	Pvp Iodine	Remel Co.	JTO	Class I	1983-12-30
K834008	Sabouraud Dextrose Agar	Micro Media Laboratories	JSJ	Class I	1983-12-30
K833968	10B	Remel Co.	JSN	Class I	1983-12-30
K833963	Haemophilus Identification Test Kit	Remel Co.	JTO	Class I	1983-12-30
K833826	Bti Biox III Oximeter Critical Careuni	Biox Technology, Inc.	DQA	Class II	1983-12-30
K833729	Elastic Breathable Over-Wrap Bandage	American Medical Disposable, Inc.	NAD	Class I	1983-12-30
K833709	Ceftizoxime 30 Mcg Antimicrobial Disk	General Diagnostics	JTN	Class II	1983-12-30
K833693	Tee Adapter 9890-Flush Winding 282	Shaban Mfg. Co.	JKS	Class I	1983-12-30