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 2191 of 3531

510(k) clearances, page 2191 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K941436	Afh, Afh Flex, Afh/t, Afh/t Flex, Af	Icor AB	BYD	Class I	1994-06-08
K941025	Phased Array Breast Coil	Medical Advances, Inc.	LNH	Class II	1994-06-08
K940974	Eyeclose External Eyelid Weights	Meddev Corp	MML	Class II	1994-06-08
K940408	Remote Console	Robinson Engineering Teleradiology System	LMD	Class I	1994-06-08
K940391	Peregrine Reverse Cutting Knife Light Pipe	Peregrine Surgical, LLC.	HQE	Class II	1994-06-08
K940332	Model Forty Ultra Compact Video Imager	International Imaging Electronics	LMC	Class II	1994-06-08
K934107	Black Oval-Top Torp/porp	Smith & Nephew Richards, Inc.	ETA	Class II	1994-06-08
K932626	Cabot Medical Surgiflex(r) Suction-Irrigation Prob	Cabot Medical Corp.	GCJ	Class II	1994-06-08
K932481	Sl-Plus and Slr-Plus	Encore Orthopedics, Inc.	JDI	Class II	1994-06-08
K931764	HF Resection Electrode, Loop W/runner Hyster/acces	Olympus Corp.	HIH	Class II	1994-06-08
K925936	Lifepak 300 Automatic Advisory Defrillator	Physio Control, Inc.	MKJ	Class III	1994-06-08
K942100	Model Tm Ep High Voltage Generator	Continental X-Ray Corp.	IZO	Class I	1994-06-07
K940572	Merocel(r) Wound Dressing (with Hemostatic Claim)	Merocel Corp.	KMF	Class I	1994-06-07
K940200	Excel Tx	Excel Tech., Ltd.	ITH	Class II	1994-06-07
K940156	The Reel Thing	Bio-Medical Devices, Inc.	GBX	Class I	1994-06-07
K935077	Cath-Seal	Universal Medical Instrument Corp.	DYB	Class II	1994-06-07
K933368	TENS-It	Electro Med Supply, Inc.	GZJ	Class II	1994-06-07
K933330	Aesculap Manual Endoscopic Instruments	Aesculap Inc	GCJ	Class II	1994-06-07
K933281	S.o.s. Proximal Femur	Wrightmedicaltechnologyinc	JDI	Class II	1994-06-07
K932913	Ferris Polymem Hydrophilic Wound Dressing	Ferris Mfg. Corp.	KMF	Class I	1994-06-07
K931884	Sullivan Nasal Vpap System	Rescare, Ltd.	BZD	Class II	1994-06-07
K931690	Spoon Plate	Onyx Medical LLC	HRS	Class II	1994-06-07
K925960	Forceps for Laparoscopic Surgery Ob/gyn Use	Zinnanti Surgical Instruments, Inc.	HFI	Class II	1994-06-07
K925957	Scissors for Laparoscopic Surgery Ob/gyn Use	Zinnanti Surgical Instruments, Inc.	HFI	Class II	1994-06-07
K942407	Amcon Slip in Mydriatic Sunglasses	Amcon Laboratories, Inc.	HOY	Class I	1994-06-06
K942367	Axt 1400 Spotfilm Device	Applied X-Ray Technologies, Inc.	IXL	Class II	1994-06-06
K942237	Sunglasses	Sun Wellen, Inc.	HQY	Class I	1994-06-06
K942065	Disposable ENT Punch	United States Surgical, A Division of Tyco Healthc	LRC	Class I	1994-06-06
K941723	Welch Allyn Glaucoma Detector	Welch Allyn Inc	HOO	Class I	1994-06-06
K941687	Children's Sunglasses	Merchandising/Imports	HQY	Class I	1994-06-06
K941607	Ucl Multifocal Soft Contact Lens	United Contact Lens Inc	LPL	Class II	1994-06-06
K941592	Weight Bag	Biocor, Inc.	KPR	Class II	1994-06-06
K941518	Dupont Cronex Portable Grid Cassette	Dupont Medical Products	IXA	Class II	1994-06-06
K941432	Non-Prescription Sunglasses	Large River Industrial Co., Ltd.	HQY	Class I	1994-06-06
K941243	Oralspring Plus Battery-Powered Toothbrush	Oraline, Ltd.	JEQ	Class I	1994-06-06
K941177	Angiorex Cas-05A	Toshiba America Medical Systems, In.C	IZI	Class II	1994-06-06
K941136	Knot Slide 8383.55 and 8383.551	Richard Wolf Medical Instruments Corp.	GCJ	Class II	1994-06-06
K941119	Xiamen Dynasty Optical Corp	Xiamen Dynasty Optical Corp., Ltd.	HQY	Class I	1994-06-06
K941009	Disposable Prophy Angle	Allpro, Inc.	EGS	Class I	1994-06-06
K940746	Vit Cutter Model 94	Visioncare Devices, Inc.	HQE	Class II	1994-06-06
K940659	Sunglasses	Leonardo, Inc.	HQY	Class I	1994-06-06
K936075	Reusable, Hand Controlled Esp	E & M Engineering, Inc.	GEI	Class II	1994-06-06
K936063	Powder Free Latex Exam Gloves W/polysil-Dc929	Hartalega Sdn Bhd	LYY	Class I	1994-06-06
K936062	Powder Free Latex Exam Gloves W/polysil-Dc24	Hartalega Sdn Bhd	LYY	Class I	1994-06-06
K935484	Provident Hip System	Globus Medical, Inc.	LPH	Class II	1994-06-06
K934192	Parapost Xt System	Coltene /Whaledent AG	ELR	Class I	1994-06-06
K933867	Universal Inset Patella	Johnson & Johnson Orthopaedics, Inc.	JWH	Class II	1994-06-06
K933021	Model T131 Memory Transmitter	Biometric Products, Inc.	DXH	Class II	1994-06-06
K931825	Cd-Chex Cd4 Low	Streck Laboratories, Inc.	GGL	Class II	1994-06-06
K931794	Marinr Series Ep Diagnostic Catheters	Medtronic Cardiorhythm	DRF	Class II	1994-06-06