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 2026-10-19, 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 3040 of 3529

510(k) clearances, page 3040 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K843593	Surgipress Surgical Loop	Syntex Corp.	HRQ	Class I	1984-10-24
K843589	Ticlip Sterial Disposable	Western Medical Products, Inc.	FZP	Class II	1984-10-24
K843575	Derbyshire Drain	Sil-Med Corp.	GBW	Class I	1984-10-24
K843562	Msi Surgi-Grade Deluxe Cut-Down Tray	Medical Sterilization, Inc.			1984-10-24
K843561	Msi Surgi-Grade Universal Trach Tray	Medical Sterilization, Inc.	FSM	Class I	1984-10-24
K843559	Kleenit by Qmed	Qmed, Inc.			1984-10-24
K843400	Hydro-Splint a Sponge-Compress Dress	Compression Splint Products, Inc.	FYH	Class I	1984-10-24
K843383	Medi-Tech Dilatation Catheters	Medi-Tech, Inc.	LIT	Class II	1984-10-24
K843280	Malleable Penile Prosthesis	Mentor	FAE	Class II	1984-10-24
K843168	Enteral Feeding Pump 14-800 Series	Biosearch Medical Products, Inc.	FRN	Class II	1984-10-24
K843038	Disposable Patient Blanket	Anago, Inc.	KME	Class I	1984-10-24
K842626	Hip Prosthesis Pack	DeRoyal Industries, Inc.			1984-10-24
K842200	Md308h Digital/mb351h Auto-Bp Monitor	Sharp Electronics Corp.	DXN	Class II	1984-10-24
K842083	Jimmy John III	Colon Therapeutics	KPL	Class II	1984-10-24
K841868	Mingograf 7	Siemens Medical Solutions USA, Inc.	DSH	Class II	1984-10-24
K841613	Pressure Transducer Dome 1295C	Hewlett-Packard Co.	DRS	Class II	1984-10-24
K844042	Blood Dilution Vial	American Scientific Products	GKL	Class II	1984-10-23
K843935	Modification Microtrak Direct Specimen Test	Syva Co.	LIO	Class I	1984-10-23
K843785	Wisss Pediatric Trach- Tube W/obturator	Intl. Medical Devices, Ltd.	BTO	Class II	1984-10-23
K843723	Sterile Instrument Trays-Various	E.M. Adams Co., Inc.	FSM	Class I	1984-10-23
K843653	Campylocacter Supplement	Institute Virion, Ltd.	JSJ	Class I	1984-10-23
K843642	Subclavian Lead Introducer Sys	Xanmed Corp.	DYB	Class II	1984-10-23
K843641	Catheter Introducer System	Xanmed Corp.	DYB	Class II	1984-10-23
K843563	Msi Surgi-Grade Incision & Drain Tray	Medical Sterilization, Inc.	FSM	Class I	1984-10-23
K843448	Scimed Pm200 Inflation Manometer	Scimed Life Systems, Inc.	MAV	Class II	1984-10-23
K843422	Ohmeda Bain Circuit Adapter Gms Absor	GE Healthcare	BSF	Class I	1984-10-23
K843207	Reptilase -Pc	Bio/Data Corp.	JCO	Class II	1984-10-23
K843093	Retic-Chex	Streck Laboratories, Inc.	JPK	Class II	1984-10-23
K842818	Cst	BD Becton Dickinson Vacutainer Systems Preanalytic	JCF	Class I	1984-10-23
K842622	Hemo Static/esu Scalpel System	Oximetrix, Inc.	GEI	Class II	1984-10-23
K842009	Abdominal Paracentesis Tray	Jayco Pharmaceuticals	FSM	Class I	1984-10-23
K841961	Mills Operative Peripheral Angioplasty	Scimed Life Systems, Inc.	LIT	Class II	1984-10-23
K841483	All Purpose Electrosurgical Generator	Concept, Inc.	GEI	Class II	1984-10-23
K834424	Sfp Agar Plates	Otisville Biotech, Inc.	JSJ	Class I	1984-10-23
K834423	S S Agar Plate	Otisville Biotech, Inc.	JSI	Class I	1984-10-23
K834422	Phenylethyl Alcohol Agar Plate	Otisville Biotech, Inc.	JSJ	Class I	1984-10-23
K834420	Mannitol-Salt Agar Usp Plate	Otisville Biotech, Inc.	JSI	Class I	1984-10-23
K834419	Columbia Cna Agar Plate	Otisville Biotech, Inc.	JSJ	Class I	1984-10-23
K843903	Heated Respiratory Humidifier Mr428	Fisher & Paykel Allied Products, Ltd.	BTT	Class II	1984-10-22
K843822	Mea110	Canadian Medical Products	GZJ	Class II	1984-10-22
K843710	Elisa for Total Ige	Scientific Research	DGC	Class II	1984-10-22
K843604	Richard Arthroscope	Richards Medical Co., Inc.	HRX	Class II	1984-10-22
K843513	Epicardia, Pc	Medicomp, Inc.	DSI	Class II	1984-10-22
K843449	Autodynamic Compression Hip Screw-Plate	Mecron Medical Products, Inc.	KTT	Class II	1984-10-22
K843343	Medica Iif-Anti-Thyroid Antibody Test	Medical Diagnostics, Ca.	JZO	Class II	1984-10-22
K843282	Universal by Rush-Hampton Arthroscopic	Rush Hampton Industries	BWH	Class II	1984-10-22
K842158	Salicylate Assay Kit	Diagnostic Chemicals, Ltd. (USA)	DKJ	Class II	1984-10-22
K841580	Tsh Receptor Antibody Kit 125I Tsh	Clinetics Corp.	JZO	Class II	1984-10-22
K841088	Somatomedin-C Radioimmunoassay Kit	Nichols Institute Diagnostics	CFL	Class I	1984-10-22
K843836	Thermal Grayscale RF-100	Fukuda Denshi USA, Inc.	DSF	Class I	1984-10-19