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 2284 of 3531

510(k) clearances, page 2284 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K932134	Rinn Universal Collimator	Rinn Corp.	IZX	Class II	1993-07-26
K931946	Welch Allyn Earcleaner	Welch Allyn Inc	KYZ	Class I	1993-07-26
K930834	Acutract	Acu Med, Inc.	HWC	Class II	1993-07-26
K930592	Ace Universal Reconstruction Plate	Ace Medical	HRS	Class II	1993-07-26
K930246	Mammorx	Diacor, Inc.	IYE	Class II	1993-07-26
K930122	Model 600Ge-64: Bilateral Breast Coil	Medical Advances, Inc.	LNH	Class II	1993-07-26
K930085	Vitalograph Data Storage Spirometer	Vitalograph, Inc.	BTY	Class II	1993-07-26
K930045	Model #Qsc-200-21 20 Cm. Quadrature Shoulder Coil	Mri Devices Corp.	LNH	Class II	1993-07-26
K925759	Uni I	Rudolf Riester GmbH & Co. KG	ERA	Class I	1993-07-26
K924367	Ogden Anchor	Advanced Surgical Implants, Inc.	JDR	Class II	1993-07-26
K923180	Specturn, Model Ttk-128	Harpell Assoc., Inc.	IYX	Class I	1993-07-26
K932725	B-D Ultra Fine(r) Lancet	BD Becton Dickinson Vacutainer Systems Preanalytic	FMK	Class II	1993-07-23
K932711	Precision Med Products Ltd Guedel Airways	Precision Med Products, Ltd.	BTR	Class II	1993-07-23
K932710	Gas Sampling Lines and Connectors	Precision Med Products, Ltd.	CAI	Class I	1993-07-23
K932709	Precision Med Products Ltd Hyperinflation System	Precision Med Products, Ltd.	BZR	Class II	1993-07-23
K932708	Precision Med Products Ltd Mapleson D Circuits	Precision Med Products, Ltd.	CAI	Class I	1993-07-23
K932707	Adult Anesthesia Breathing Circuit	Precision Med Products, Ltd.	CAI	Class I	1993-07-23
K932706	Precision Med Products Ltd. Ventilator Hose	Precision Med Products, Ltd.	BZO	Class I	1993-07-23
K932562	Gas Sampling Lines and Connectors	Life Shield Healthcare Products, Inc.	CAI	Class I	1993-07-23
K932354	9170, 1170	Dynarad Corp.	IZL	Class II	1993-07-23
K931995	Resectoscope Sheath	Olympus Corp.	FJL	Class II	1993-07-23
K931727	Urinary Drainage Bag Caddy	Neotech Products, LLC	FAQ	Class I	1993-07-23
K931480	Cleanblade	Cleanblade, Inc.	GEI	Class II	1993-07-23
K931306	Eclipse 3200 for Use in Ortho Surg/arth Appl Joint	Cardiogenes	GEX	Class II	1993-07-23
K931281	Micro Endoscopic Electrode (Me2)	Cerenovus, Inc.	GCJ	Class II	1993-07-23
K931278	Intherm Single-Stick Radially Expanding Dilator	Interventional Therapeutics Corp.	GCJ	Class II	1993-07-23
K930733	Ureteral Stent	Surgitek	FAD	Class II	1993-07-23
K930716	Laparoscopic Cholecystectomy Instrumentation	Gabris Surgical Corp.	GCJ	Class II	1993-07-23
K930572	Nezhat-Dorsey Hydro-Dissection System II Pump	American Hydro-Surgical Instruments, Inc.	GCJ	Class II	1993-07-23
K930512	Suction/irrigation Y Tubing Set W/trumpet Valves	Core Dynamics, Inc.	GAZ	Class II	1993-07-23
K930474	Needle, Pneumoperitoneum, Spring Loaded	Ranfac Corp.	FHO	Class II	1993-07-23
K926300	Dtx-100	Hologic, Inc.	KGI	Class II	1993-07-23
K926089	Kensey Nash Wuik-Sert(tm) Endoscopic Surg Grasper	DSM Biomedical, Inc.	GCJ	Class II	1993-07-23
K925670	Ims-200	Intelligent Medica Imaging, Inc.	JOY	Class II	1993-07-23
K925290	Catalog Number 111 (Faceshield)	Ansley Medical Products, Inc.	LYU	Class I	1993-07-23
K924881	Reflex(r) Esp	Richard-Allan Medical	GEI	Class II	1993-07-23
K923589	Sterile Hypoallergenic Powder-Free Latex Surg. Glv	Tomarc (M) Sdn Bhd	LYY	Class I	1993-07-23
K921547	Advantage	Kci	FMT	Class II	1993-07-23
K921182	Ultra High Molecular Weight Polyethylene Component	Zimmer GmbH	JWH	Class II	1993-07-23
K932927	Srx Comp Ultralight Wheelchair	Medical Composite Technology, Inc.	IOR	Class I	1993-07-22
K932795	Haverich Orthopaedic Cycles	Haverich Ortho-Sport (USA), Inc.	IOR	Class I	1993-07-22
K932754	Abuscreen Calibration Standard	Roche Diagnostic Systems, Inc.	DKB	Class II	1993-07-22
K932753	Roche Abuscreen Tri-Level Reference Controls	Roche Diagnostic Systems, Inc.	DKB	Class II	1993-07-22
K932749	Model M4501,m4502,m4503,m4504,m4505 Tilt Table	Med Mart, Inc.	INQ	Class I	1993-07-22
K932712	Precision Med Products Ltd Volume Ventilators	Precision Med Products, Ltd.	BZO	Class I	1993-07-22
K932639	Manual Tilt Recline Chair (Mtc)	Labac Systems, Inc.	IOR	Class I	1993-07-22
K932590	Adult Gas Sampling Circuits	Merit Medical Systems, Inc.	CAI	Class I	1993-07-22
K932589	Pediatric Gas Sampling Circuits	Merit Medical Systems, Inc.	CAI	Class I	1993-07-22
K932578	Adult Gas Sampling Circuits	Med-Plastics Intl., Inc.	CAI	Class I	1993-07-22
K932577	Pediatric Gas Sampling	Med-Plastics Intl., Inc.	CAI	Class I	1993-07-22