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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 2305 of 3531

510(k) clearances, page 2305 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K925005	Isi Self-Supporting Arm	Instrumentation Specialties, Inc.	BWN	Class I	1993-04-29
K924669	Ferno-Washington Basket Stretcher, Model 71-W	Ferno	FPP	Class I	1993-04-29
K923127	Needle-Pro Cartridge	Concord/Portex	FMI	Class II	1993-04-29
K922042	Cardifix Endocardial Pacing Lead	Intermedics, Inc.	DTB	Class III	1993-04-29
K915787	Stability Hip Stem with Porocoat	Depuy, Inc.	JDG	Class II	1993-04-29
K931247	Titan Gel Immunofix-9 Cat. No. 3051 and 3067	Helena Laboratories, Corp.	DAH	Class II	1993-04-27
K930985	Usdt Cocaine/cocaine Metabol Assay Column,9000-100	U.S. Drug Testing, Inc.	DIO	Class II	1993-04-27
K930946	Dispens-O-Disc Cefpodoxime 10 Mcg.	Difco Laboratories, Inc.	JTN	Class II	1993-04-27
K930935	Endopath Tissue Extraction Cannula	Ethicon, Inc	GCJ	Class II	1993-04-27
K930923	Coag-Control	American Bioproducts Co.	GGC	Class II	1993-04-27
K930911	Dispens-O-Disc Clarithromycin 15 Mg.	Difco Laboratories, Inc.	JTN	Class II	1993-04-27
K930558	Mortara Instrument, Inc. E-Scribe	Mortara Instrument, Inc.	DPS	Class II	1993-04-27
K930350	Radman Image Managment System	Infocure Systems, Inc.	LMD	Class I	1993-04-27
K930338	Orthoceph Oc100	Instrumentarium Corp.	EHD	Class II	1993-04-27
K930249	Bc/wt/pf	Tingle X-Ray Products, Inc.	IXY	Class I	1993-04-27
K930230	Radiographic Wall-Mounted Cassette Holder	American Medical Sales, Inc.	IXY	Class I	1993-04-27
K930219	Kendall Curity 20 Gauge Continuous Epidual Anesthe	Kendall Healthcare Products Co. Div.Of Tyco Health	BSO	Class II	1993-04-27
K930022	Sphincterotome	Boston Scientific Corporation	FDI	Class II	1993-04-27
K926171	Mrt-150A, Qd Spine Coil	Toshiba America Mri, Inc.	LNH	Class II	1993-04-27
K926064	Fluoroscopic Brightness Stabalizer/fbs Model 9205A	Scientific Technology, Ltd.	JAA	Class II	1993-04-27
K926012	Acs Apct Reagent, Modified	Analytical Control Systems	GFO	Class II	1993-04-27
K925083	Endotrak System	Instratek, Inc.	HRX	Class II	1993-04-27
K924808	Mrt-50A Super	Toshiba America Mri, Inc.	LNH	Class II	1993-04-27
K924140	Tuff Ties	Glenroe Technologies	ECI	Class I	1993-04-27
K923944	Philips Gyroview Hr - Release 2	Philips North America LLC	LNH	Class II	1993-04-27
K922703	The Acta Formula	Biosound, Inc.	DPS	Class II	1993-04-27
K922235	System 97	Datascope Corp.	DSP	Class II	1993-04-27
K921436	Sonicator Plus	Mettler Electronics Corp	IMG	Class II	1993-04-27
K921112	Fuji Computed Radiography Od-F623 Optical-Disk	FUJIFILM Healthcare Americas Corporation	KPR	Class II	1993-04-27
K925022	Surgical Tray (Sterile)	Customed, Inc	LRD	Class I	1993-04-26
K925016	Prep Shave Kit (Non-Sterile)	Customed, Inc	LRO	Class II	1993-04-26
K931345	Connectors and Airway Extensions	Precision Med Products, Ltd.	BZA	Class I	1993-04-23
K931217	Breathing Filter	Teknor Medical Products, Inc.	CAH	Class II	1993-04-23
K931216	Connectors and Airway Extensions	Teknor Medical Products, Inc.	BZA	Class I	1993-04-23
K930775	Disposable Forceps, Hemostats, Needle Guides, Etc	Falcon Instruments, Inc.	MDM	Class I	1993-04-23
K930720	Vogues-Proskauer Reagent a & B	Hardy Diagnostics	JTO	Class I	1993-04-23
K930718	Indole Spot & Indole Kovacs Reagent	Hardy Diagnostics	JTO	Class I	1993-04-23
K930717	Nitrate Reagents a, B and C	Hardy Diagnostics	JTO	Class I	1993-04-23
K930210	Acl-5500	Ilt Systems, Inc.	GEX	Class II	1993-04-23
K930165	Ae-207D Tympanometer	Amrex Electronics, Inc.	ETY	Class II	1993-04-23
K930164	The Automatic Impedance Meter,model Ae-208D/s	American Electromedics Corp.	ETY	Class II	1993-04-23
K930086	Ortholux Xt	3M Company	EBZ	Class II	1993-04-23
K926556	Vivalux	Ivoclar North America, Inc.	EBF	Class II	1993-04-23
K926415	Valleylab Current Monitor, E3350 & E3351	Medtronic, Inc.	GEI	Class II	1993-04-23
K925932	Canuseal	Lap Associates of Nashville, Ii, Inc.	GCJ	Class II	1993-04-23
K925860	Modified Auto Suture Surgiport Premium Seal	United States Surgical, A Division of Tyco Healthc	GCJ	Class II	1993-04-23
K925129	Selector	Spembly Medical, Ltd.	GCJ	Class II	1993-04-23
K924424	Unimedix Holmium Fiber	Unimedix, Inc.	GEX	Class II	1993-04-23
K924333	The Davis Disposable Protective Splint	Ora-Gard, Inc.	JXL	Class II	1993-04-23
K924281	Harmonic Scalpel Laparosonic Blade Accessory	Ultracision, Inc.	GCJ	Class II	1993-04-23