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 2250 of 3531

510(k) clearances, page 2250 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K934063	Panoramic X-Ray Units, Modification	Planmeca Oy	EHD	Class II	1993-12-15
K933963	Pal (Personal Amplifier for Listening)	Hearing Care Products, Inc.	ESD	Class I	1993-12-15
K933664	Polytron T.o.p. (Time, Operation, Performance)	Siemens Gammasonics, Inc.	IZI	Class II	1993-12-15
K933267	Autoantibody Profile-6 Elisa Test System	Zeus Scientific LLC	LJM	Class II	1993-12-15
K932616	Scimed(r) Dispatch(tm) Coronary Infusion Catheter	Scimed Life Systems, Inc.	KRA	Class II	1993-12-15
K932268	Modifications to Intra-Aortic Balloons	Kontron Instruments, Inc.	DSP	Class II	1993-12-15
K932259	Clarus Model 2240 Semi-Rigid Otoscope	Clarus Medical Systems, Inc.	ERA	Class I	1993-12-15
K932163	Blom-Singer Voice Prosthesis Flushing Pipet	Freudenberg Medical, LLC	EWL	Class II	1993-12-15
K931865	Pyr Test Kit	Hardy Diagnostics	JTO	Class I	1993-12-15
K931864	Martin Lewis with Linocmycin	Hardy Diagnostics	JTY	Class II	1993-12-15
K931672	Carapace Sterile Cast Padding	Carapace, Inc.	LGF	Class I	1993-12-15
K935034	Laser Gas Mixture	Tri-Gas, Inc.	GEX	Class II	1993-12-14
K934832	Impax 3000	Kulzer GmbH	JAK	Class II	1993-12-14
K934310	Bageasy(r) III Adult Disposable Manual Resuscitator	Respironics, Inc.	BTM	Class II	1993-12-14
K934186	Forceps, Biopsy, Gastrointestinal	Primed Instruments, Inc.	FCL	Class I	1993-12-14
K933830	Konica Ld-4500 Laser Digitizer	Konica Medical Corp.	LMA	Class II	1993-12-14
K933356	Merit	Philips North America LLC	LNH	Class II	1993-12-14
K933208	Bare-Fiber Endoilluminator	Surgical Technologies, Inc.	HQE	Class II	1993-12-14
K933050	Changes to Protectiv(tm) & Jelco(tm) Winged Cath	Critikon Company, LLC	FOZ	Class II	1993-12-14
K932638	Huber Needle Infusion Set	Douglas Medical Products, Inc	FPA	Class II	1993-12-14
K932376	Zeiss Opmilas 144 Surgical Lasers	Carl Zeiss, Inc.	GEX	Class II	1993-12-14
K932091	Phased Array/bilateral Quadrature Contour Coil	Magnetic Research, Inc.	LNH	Class II	1993-12-14
K931656	Merit	Picker International	LNH	Class II	1993-12-14
K931454	Imageaccess System	Image Premastering Services, Inc.	LNH	Class II	1993-12-14
K931317	Konica Srx-301 Automatic X-Ray Film Processor	Konica Medical Corp.	IXW	Class II	1993-12-14
K931316	Konica Ds-7 Automatic X-Ray Film Processor	Konica Medical Corp.	IXW	Class II	1993-12-14
K931315	Konica Srx-501A Automatic X-Ray Film Processor	Konica Medical Corp.	IXW	Class II	1993-12-14
K930012	Kawasumi Laboratories K-Cuff	Kawasumi Laboratories Co., Ltd.	KZD	Class I	1993-12-14
K935209	Insta-Flo	Medtec LLC	JAD	Class II	1993-12-13
K935068	Radiographic Generator Hfq-Whis	Bennett X-Ray Corp.	IZO	Class I	1993-12-13
K935004	Model Alpha Ts-2	Dpa Consulting, Inc.	IYB	Class I	1993-12-13
K934967	Shimadzu Ud150l-R X-Ray High Voltage Generator	Shimadzu Corp.	IZO	Class I	1993-12-13
K934519	Radiation Exit Verification System/back Pointer System	Medtec LLC	IWE	Class I	1993-12-13
K934496	X-Ray Angiographic System	Camtronics, Ltd.	IZI	Class II	1993-12-13
K934311	Intrascan(r) Mini-Pacs	Markcare Medical Systems, Inc.	IYO	Class II	1993-12-13
K934184	Fastfil	Scientific Pharmaceuticals, Inc.	EMA	Class II	1993-12-13
K933829	Pulse Electric Toothbrush	Dentatech Corp.	JEQ	Class I	1993-12-13
K933812	Advanced Surgical, Inc. Cannula Cleaning Device and Accessories	Advanced Surgical, Inc.	GCJ	Class II	1993-12-13
K933778	Whitmore Ankle X-Ray Extension (Axe)	Whitmore Ent., Inc.	KPR	Class II	1993-12-13
K933777	Concept One	Innerscan, Inc.	IZO	Class I	1993-12-13
K933689	Modification of Kendall Curasorb Calcium Alginate Wound Dressing	Kendall Healthcare Products Co. Div.Of Tyco Health	KMF	Class I	1993-12-13
K933632	Medscan 12	Vidar Systems Corp.	LMA	Class II	1993-12-13
K933159	Xyz Pads	Aso LLC	EFQ	Unclassified	1993-12-13
K933151	Convenience Contour Kits Redi Nurse System	Contour Fabricators of Florida, Inc.	FRG	Class II	1993-12-13
K932645	Philips Gyroscan Tn 15	Philips North America LLC	LNH	Class II	1993-12-13
K932644	Philips Gyroscan Tn5 & Tn5 Lite	Philips North America LLC	LNH	Class II	1993-12-13
K932410	Heartview(r) Coronary Angiograph Diagram/report Sy	Heartware Intl. Corp.	IZI	Class II	1993-12-13
K932400	Espocan Combined Spinal/epidural Needle Set & Tray	B. Braun of America, Inc.	BSP	Class II	1993-12-13
K932361	Basic Skin Prep Tray	Mcbar Industries	FMF	Class II	1993-12-13
K932342	Model 500-6 Radiation Therapy Ionization Chamber	Victoreen, Inc.	LNN		1993-12-13