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 2147 of 3531

510(k) clearances, page 2147 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K945109	Monoject Bone Marrow Biopsy Trays	Sherwood Medical Co.	GAA	Class I	1994-11-14
K944949	General Anesthesia System	Vital Signs, Inc.	BTK	Class I	1994-11-14
K944821	Model 5151	Richard Wolf Medical Instruments Corp.	GCT	Class II	1994-11-14
K944815	Scimed Viper Percutaneous Transluminal Angioplasty (Pta) Catheter	Scimed Life Systems, Inc.	LIT	Class II	1994-11-14
K944641	Nil	Max-Vision (H.K.)Limited	HQZ	Class I	1994-11-14
K944548	Rexplus Pp3	Rexton, Inc.	ESD	Class I	1994-11-14
K944341	Royal Plastic Sunglasses	Royal Plastic SARL	HQY	Class I	1994-11-14
K944261	Retina Angiograph	Heidelberg Engineering GmbH	HLI	Class II	1994-11-14
K944202	Abbott a-Gent Liquid Magnesium Reagent, Modified	Abbott Medical	JGJ	Class I	1994-11-14
K944081	Olympus Switching Unit Model Su-1	OLYMPUS Corporation of the Americas	FET	Class II	1994-11-14
K943956	Retina Tomograph and Flowmeter	Heidelberg Engineering GmbH	HLI	Class II	1994-11-14
K943955	Retina Flowmeter	Heidelberg Engineering GmbH	HLI	Class II	1994-11-14
K943078	Hot Biopsy Forceps	Intl. Medical, Inc.	KGE	Class II	1994-11-14
K942917	Ultrapro Workstation	Ramsoft, Inc.	LMD	Class I	1994-11-14
K942868	Acutome 2000 Color-Corrected Laparoscopic C02 Laser Coupler and Sleeves	Reliant Laser Corp.	GEX	Class II	1994-11-14
K942077	Bi-Tec Endoscopic Bipolar Instruments	Linvatec Corporation	GEI	Class II	1994-11-14
K941348	Kronner Laparoscopic Holder	Kronner Prototypes, Inc.	GCJ	Class II	1994-11-14
K941285	Arthrex Graft Harvesting Kit	Arthrex GmbH	KIJ	Class I	1994-11-14
K941167	Non-Invasive Blood Pressure (Nibp) Monitor (Model 90553)	GE Healthcare	DXN	Class II	1994-11-14
K940712	Ppm III	O-Two Systems Intl., Inc.	CBP	Class II	1994-11-14
K940673	J.b.s. Self-Tapping Threaded Pin	J.B.S., S.A.	HTY	Class II	1994-11-14
K940669	J.b.s. B.a.c. Pin	J.B.S., S.A.	HTY	Class II	1994-11-14
K940666	Jbs Smooth Fixation Pin	J.B.S., S.A.	HTY	Class II	1994-11-14
K940151	Ultrasound Probe Drape	Hydro-Med Products, Inc.	IYO	Class II	1994-11-14
K936256	Modular Ceramic Femoral Head	Globus Medical, Inc.	LZO	Class II	1994-11-14
K933285	Datex As/3 Tm Anaesthesia Monitor	Datex Division Instrumentarium Corp.	BSZ	Class II	1994-11-14
K932414	Continuous Cardiac Output System	Abbott Medical	DXG	Class II	1994-11-14
K931021	Shimasonic Sdu-400 Electronic Linear/convex D.u.s.	Shimadzu Medical Systems	IYO	Class II	1994-11-14
K945214	Medi-Trace Neonatal ECG Electrode with Preattached Leadwire	Graphic Controls Corp.	DRX	Class II	1994-11-10
K945001	Sunglasses	Long Sheng Optical Co., Ltd.	HQY	Class I	1994-11-10
K944566	Vacutainer Brand Plus Sodium Heparin Tube	BD Becton Dickinson Vacutainer Systems Preanalytic	JKA	Class II	1994-11-10
K944484	Kodi Optical Co., Ltd. Sunglasses	Kodi Optical Co., Ltd.	HQY	Class I	1994-11-10
K944371	Tobramycin Fpia Reagent Set and Calibrator	Sigma Diagnostics, Inc.	LFW	Class II	1994-11-10
K944333	Hydroderm Gel Wound Dressing	Wilshire Medical Products	MGQ	Unclassified	1994-11-10
K944093	Dimension(r) Xl Clinical Chemistry System	E.I. Dupont de Nemours & Co., Inc.	JJE	Class I	1994-11-10
K944063	Fluorescence Polarization Immunoassay Carbamazepine	Sigma Diagnostics, Inc.	LGI	Class II	1994-11-10
K943949	Polyviolene Surgicl Suture	Look, Inc.	GAT	Class II	1994-11-10
K943866	Valproic Acid Fpia Reagent Set and Calibrators	Sigma Diagnostics, Inc.	LEG	Class II	1994-11-10
K943761	Non-Breathing Valve	Rondex Products, Inc.	CBP	Class II	1994-11-10
K943148	Dsl Active 17A-Oh Progesterone Ria (Dsl 5000)	Diagnostic Systems Laboratories, Inc.	JLX	Class I	1994-11-10
K942797	Monoclonal Mouse Anti-Human T-Cell	Dako Corp.	GKZ	Class II	1994-11-10
K942695	Tri Block Polumer Gel Sheeting	Silipos, Inc.	MDA	Class I	1994-11-10
K942451	Bio-Rad Clinical Data Management System	Bio-Rad	LDM	Class I	1994-11-10
K942370	Depuy Cemented Hip Prosthesis	Depuy, Inc.	JDI	Class II	1994-11-10
K941759	Snoring Sensor	Epm Development Systems Corp.	BZQ	Class II	1994-11-10
K941333	Se5 Arthroscopy Sytem	Stryker Corp.	HRX	Class II	1994-11-10
K941050	Dupont Aca Star	Dupont Medical Products	JJQ	Class I	1994-11-10
K941008	Complete CPR Kit	Mtm Health Products, Ltd.	CBP	Class II	1994-11-10
K940890	Corrugated Tubing	Cleveland Tubing, Inc.	CAI	Class I	1994-11-10
K940889	Connectors and Airway Extensions	Cleveland Tubing, Inc.	CAI	Class I	1994-11-10