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 2266 of 3531

510(k) clearances, page 2266 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K924720	Visidisc Kits, Spinescope	Laserscope	GEX	Class II	1993-10-08
K924315	The Massager	Four Directions	LYG	Class I	1993-10-08
K923194	Insufflator Connecting Filter	Procedure Products, Inc.	HIF	Class II	1993-10-08
K923126	Mallawany Tissue Grasping Forceps	Numed Technologies, Inc.	HET	Class II	1993-10-08
K921852	4 Sure Tm Rectal Tube	Boston Pacific Medical, Inc.	KMO	Class I	1993-10-08
K921417	Uresil Laparoscopic Retractor	Uresil, LLC	HET	Class II	1993-10-08
K921386	Suop Electrodes for Excisional Procedures	Silver Creek Surgical	HGI	Class II	1993-10-08
K934359	Scimed Strike Steerable Guide Wire	Scimed Peripheral Interventions	DQX	Class II	1993-10-07
K934206	Mavig Angio Shield Models 6290 & 6272	F. Walter Hanel GmbH	KPY	Class I	1993-10-07
K934122	Scimed Transend Ex Steerable Guide Wire and Accessories	Scimed Peripheral Interventions	DQX	Class II	1993-10-07
K934067	Powrpak Replacement Batteries for Phisio-Control Lifepak 5/10	National Custom Ent., Inc.	DRK	Class III	1993-10-07
K933989	Resolution Itc Hearing Aid	Starkey Laboratories, Inc.	ESD	Class I	1993-10-07
K933988	Bosch Eurostar	Starkey Laboratories, Inc.	ESD	Class I	1993-10-07
K933650	Philips Xrg 90 X-Ray Generator System	Philips North America LLC	IZO	Class I	1993-10-07
K933614	Pituitary Board	Bionix Development Corp.	IYE	Class II	1993-10-07
K933613	3-Way Head Immobilizer; 3Way Deluxe Reusable Frame Head Immobilizer	Bionix Development Corp.	IYE	Class II	1993-10-07
K933407	Starkey Tympanette Hearing Aid	Starkey Laboratories, Inc.	ESD	Class I	1993-10-07
K933162	Mrx-750	Mrx Corp.	ITY	Class I	1993-10-07
K933161	Ultra-Vision Super Rapid Intensifying Screen	Dupont Medical Products	EAM	Class I	1993-10-07
K933134	Spectrum Dg-P7000 Pediatric Cradle	Spectrum X-Ray Corp.	KXH	Class I	1993-10-07
K933129	Lumiscan 50	Lumisys, Inc.	LMA	Class II	1993-10-07
K933073	Hearttrace Left Ventricular Analysis Software	Heartware Intl. Corp.	IZI	Class II	1993-10-07
K932931	D1400 Defibrillator W/ Defibrillation Advisory Opt	ZOLL Medical Corporation	MKJ	Class III	1993-10-07
K932777	Smartneedle(r) Over-the-Needle Catheter	Peripheral Systems Group	ITX	Class II	1993-10-07
K932761	Soft-Wear Headgear and Safety Modules	Professional Positioners, Inc.	DZB	Class II	1993-10-07
K932693	Edge System	Philips North America LLC	LNH	Class II	1993-10-07
K932494	Pm Pump Aspirator	Precision Medical, Inc.	BTA	Class II	1993-10-07
K931903	Surelock(tm) Snapless Monitoring Electrode	Ludlow Technical Products	DRX	Class II	1993-10-07
K931154	Evis 200 System	Olympus Corp.	EOQ	Class II	1993-10-07
K931022	Artoscan	Biosound, Inc.	LNH	Class II	1993-10-07
K930804	Filliscope	Filliscope, Inc.	CCW	Class I	1993-10-07
K930779	Mrinnervu Disposable Endorectal Cervix Coil#bcr-15	Medrad, Inc.	LNH	Class II	1993-10-07
K930128	Sr Spectrasit, Sr Chromasit	Ivoclar North America, Inc.	EBF	Class II	1993-10-07
K926272	Beckman Transferrin Kit	Beckman Instruments, Inc.	DDG	Class II	1993-10-07
K925985	Gyrex V-Dix & 2T-Dix Software Version 3.0	Elscint, Inc.	LNH	Class II	1993-10-07
K925982	Bmd Air/oxygen Blender	Biomedical Devices, Inc.	BZR	Class II	1993-10-07
K925597	Snr-3000 Upgrade Receiver Coils	Magnetic Resonance Plus, Inc.	LNH	Class II	1993-10-07
K925564	Action Medtek/dentek Eyeglasses	Action Eyewear Corp.	HOY	Class I	1993-10-07
K925286	Mrt-150A MRI System W/super Performance Package	Toshiba America Mri, Inc.	LNH	Class II	1993-10-07
K923344	Electronic Digital Blood Pressure Monitor	Citizen Watch Co., Ltd.	DXN	Class II	1993-10-07
K921220	Breathe Right	Cns, Inc.	LWF	Class I	1993-10-07
K911593	Steri-Oss Dual Coated Cylindrical Implants	Steri-Oss, Inc.	DZE	Class II	1993-10-07
K933975	Meadox Surgimed Disposable Pressure Guage for Use with the Olbert Catheter System	Meadox Medicals, Div. Boston Scientific Corp.	LIT	Class II	1993-10-06
K933626	Capno-Flo	Kirk Specialty Systems	BTM	Class II	1993-10-06
K933452	Multiple	Tae Han Optical Ent.	HQZ	Class I	1993-10-06
K933398	Bivona Illuminated Endotracheal Tube	Bivona Medical Technologies	BTR	Class II	1993-10-06
K932838	Sunglasses and Optical Frames, Carbon and Metal Frames	Wonderful Optical Co., Ltd.	HQY	Class I	1993-10-06
K932740	Homepump Nsf	Block Medical, Inc.	MED	Class II	1993-10-06
K932320	Neutralizer	Smith and Nephew Donjoy, Inc.	GZJ	Class II	1993-10-06
K931587	Multi-Port Y Introducer Set	Merit Medical Systems, Inc.	DYB	Class II	1993-10-06