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 2215 of 3531

510(k) clearances, page 2215 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K931637	A013 Femi-Form Facial Massager	Fairform Mfg., Co., Ltd	IRO	Class I	1994-03-28
K931636	Fo18/fo98 Scruboflex Showerproof Brush Massager	Fairform Mfg., Co., Ltd	ISA	Class I	1994-03-28
K931572	Link Ceramic Heads 14/16 X 32Mm	Link America, Inc.	LZO	Class II	1994-03-28
K931215	Hand-Trol S	Aspen Labs	DWG	Class II	1994-03-28
K931208	Low Profile Sleave Nut Assembly	Advanced Spine Fixation Systems, Inc.	KWP	Class II	1994-03-28
K931116	Il Test(tm) Triglyceride	Instrumentation Laboratory Co.	JGY	Class I	1994-03-28
K931107	Logyk Acetabular Component System	Arthronics, Inc.	MBL	Class II	1994-03-28
K930953	Celebrity Sc440	Pride Health Care, Inc.	INI	Class II	1994-03-28
K930952	Pride Legend Sc-340	Pride Health Care, Inc.	INI	Class II	1994-03-28
K930129	Arrow Picc-Peripherally Inserted Central Catheter	Arrow Intl., Inc.	LJS	Class II	1994-03-28
K930088	Fortress C-500 Microprocessor Controller	Fortress Scientific, Ltd.	ITI	Class II	1994-03-28
K926499	Shuttle Sc-140	Pride Health Care, Inc.	INI	Class II	1994-03-28
K926296	Celebrity Sc400	Pride Health Care, Inc.	INI	Class II	1994-03-28
K926295	Legend Sc 300	Pride Health Care, Inc.	INI	Class II	1994-03-28
K925865	Kid Power	Everest & Jennings, Inc.	ITI	Class II	1994-03-28
K924515	Electric Mobility Rascal	Electric Mobility	INI	Class II	1994-03-28
K924278	Quickie P200	Quickie Designs, Inc.	ITI	Class II	1994-03-28
K923189	Luxtron Model 3100/3101/3102 Multichannel	Luxtron	FLL	Class II	1994-03-28
K921818	Abbott Smart Cap	Abbott Medical	KDJ	Class II	1994-03-28
K921756	Electronic Insufflator Model 2054.61	Richard Wolf Medical Instruments Corp.	HIF	Class II	1994-03-28
K914548	Bryan Spinal Fixater (Bsf)	Arcan Orthopaedic Corp.	KWP	Class II	1994-03-28
K940821	Playtex Tampons #04994 Unscented & Scented	Playtex Family Products, Inc.	HIL	Class II	1994-03-25
K940641	Elias Ana Total	Elias U.S.A., Inc.	LJM	Class II	1994-03-25
K940639	Lori-Cic Hearing Aid	Lori Medical Laboratories, Inc.	ESD	Class I	1994-03-25
K940454	Grasping Forceps, Punches, Scissors	L.A.S.E.R., Inc.	HRX	Class II	1994-03-25
K940377	Unscented Menstrual Pad Tier-1 Review	Eldari, Ltd.	HHD	Class I	1994-03-25
K936182	Critikit Plus in Line Room/ice Temperature Injectate Kit	GE Healthcare	KRB	Class II	1994-03-25
K935636	Gravespec	Adept-Med Intl., Inc.	HIB	Class II	1994-03-25
K935468	Synelisa Ana Total	Elias U.S.A., Inc.	LJM	Class II	1994-03-25
K935450	Phased Array Pelvic Coil	Medical Advances, Inc.	LNH	Class II	1994-03-25
K935222	Stryker Endoscopic Electrosurgical Instruments & Accesories	Stryker Corp.	GEI	Class II	1994-03-25
K934798	Pathodx Cytomegalovirus	Siemens Healthcare Diagnostics Inc.	LIN	Class II	1994-03-25
K934720	Auto Suture Disposable Arthroscopic Trocar and Sleeve	United States Surgical, A Division of Tyco Healthc	HRX	Class II	1994-03-25
K934332	Surgical Instruments, Forceps & Graspers, Probes & Curettes	Friatec Medical Inc., USA	HRX	Class II	1994-03-25
K933492	Esys System	Endolap, Inc.	HET	Class II	1994-03-25
K933470	Endoscopic Carpal Tunnel Release System	Kinetix Instruments	HRX	Class II	1994-03-25
K932869	Arthroplane	Synvasive Technology, Inc.	HRX	Class II	1994-03-25
K931355	Whisper O2	Trilogic Corp.	CAW	Class II	1994-03-25
K930676	Action Tiger Powered Wheelchair	Invacare GmbH	ITI	Class II	1994-03-25
K926179	Sedlacek Handle	Simpson/Basye, Inc.	HGI	Class II	1994-03-25
K925295	Exacta-Spezial	Rudolf Riester GmbH & Co. KG	DXN	Class II	1994-03-25
K923843	Fogless	Sorex Medical	OCT	Class II	1994-03-25
K922632	Wom Hysteroflator Op	W.O.M. GmbH	HIG	Class II	1994-03-25
K922402	4 Sure Tm Enteral Feeding Bag	Boston Pacific Medical, Inc.	FPD	Class II	1994-03-25
K921885	E1070 & E1080 Series Reusable Lletz Electrodes	Medtronic, Inc.	HGZ	Class II	1994-03-25
K921405	Davol Suction/irrigator W/ Interchangeable Tip	Davol, Inc.	HFG	Class II	1994-03-25
K940354	Orvis Marquesas Fishing Glasses	The Orvis Co., Inc.	HQY	Class I	1994-03-24
K940292	Orvis River Guide Glasses	The Orvis Co., Inc.	HQY	Class I	1994-03-24
K940275	Universal Cushioned Polycarbonat Eye Shield	P.J. Products, Inc.	HOY	Class I	1994-03-24
K940266	Bei Medical Systems' Smoke Evacuator	Bei Medical Systems Co., Inc.	FYD	Class II	1994-03-24