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 2320 of 3531

510(k) clearances, page 2320 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K923888	Devilbiss Model 5650 Pulmo-Aide	Devilbiss Health Care, Inc.	CAF	Class II	1993-02-23
K923811	Compel Surgical Drapes	Standard Textile Co., Inc.	KKX	Class II	1993-02-23
K923420	Ciba Corning Magic Lite Sq Specific Ige Assay	Ciba Corning Diagnostics Corp.	DHB	Class II	1993-02-23
K923418	9293/1 Interface Module	S & W Medico Teknik	DQA	Class II	1993-02-23
K923316	Expresso Cartridge	Bio-Rad Laboratories Inc.	JQP	Class I	1993-02-23
K923254	Therabeam Infrared Heat Lamp	Strategic Alliances Corp.	ILY	Class II	1993-02-23
K922952	Songer Cable System	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	JDQ	Class II	1993-02-23
K922089	Pneumatherm	National Pain Institute	IRT	Class II	1993-02-23
K922060	.25' Ultra-Select Guidewire	Microvena Corp.	DQX	Class II	1993-02-23
K911058	Techmedica Cad/cam Custom Hip	Techmedica, Inc.	JDI	Class II	1993-02-23
K926450	Edslab(r) Dual Lumen Region Satur Oximetry Cath	Baxter Healthcare Corporation	DQE	Class II	1993-02-22
K925809	Compressar Universal (Tm) System	Instromedix, Inc.	DXC	Class II	1993-02-22
K924654	First Metatarsophalangeal Joint Motion Splint	Sutter Corp.	BXB	Class I	1993-02-22
K923117	Cavernosometry Module for Menuet	Dantec Medical, Inc.	DXT	Class II	1993-02-22
K915130	Mat Membrane Autotransfusion System	Estracorporeal, Inc.	CAC	Class II	1993-02-22
K926250	Electromedics El-Series Cardiotomy Reservoir	Electromedics, Inc.	DTN	Class II	1993-02-19
K925881	Disposable Biopsy Forcep	Neuro Navigational Corp.	GWG	Class II	1993-02-19
K924445	Ba-4 Wall Bucky and Ba-42 Tilting Wall Bucky	Control-X, Inc.	IXY	Class I	1993-02-19
K923985	Unscented Menstrual Tampon	Personal Products Co.	HEB	Class II	1993-02-19
K923887	Jack's Vent Tubes	O.R. Specialties, Inc.	ETD	Class II	1993-02-19
K923479	Disposable Neuroview Endoscope	Neuro Navigational Corp.	GWG	Class II	1993-02-19
K923073	Automatic Tympanometer	Life-Tech Intl., Inc.	ETY	Class II	1993-02-19
K922826	Flexible Fiber Optic Endoscope	Optimed Technologies, Inc.	FGA	Class II	1993-02-19
K920808	Ob/gyn Drape	Preferred Medical Products, LLC	KKX	Class II	1993-02-19
K920554	Kold Wrap Sterile Burn Dressing	Kold Products	MGQ	Unclassified	1993-02-19
K920113	Bird Graphics Monitor	Bird Products Corp.	CBK	Class II	1993-02-19
K915574	Comfort Personal Lubricant	Hyman, Phelps & McNamara, P.C.	KMJ	Class I	1993-02-19
K926511	Synermed Single Reagent Creatinine Kit	Synermed, Inc.	CGX	Class II	1993-02-18
K925906	Normal Angiotensin Converting Enzyme Control	Analytical Control Systems	JJX	Class I	1993-02-18
K925855	Disposable Uncuffed Endotracheal Tube	Coast Medical Corp.	BTR	Class II	1993-02-18
K925035	Midkiff Geostatic Clamp	D.L. Nelson and Assoc., Inc.	FWZ	Class I	1993-02-18
K924354	Stockert Caps Low Level Detect Ii/bubble Monitor	Sorin Biomedica, Fiat, USA, Inc.	DTW	Class II	1993-02-18
K923698	Betamist 2	Rantran, Inc.	CAF	Class II	1993-02-18
K923558	ECG Electrode	Lectec Corp.	DRX	Class II	1993-02-18
K923170	Los Alamos Retractable Knife	Innovative Surgical Technology, Inc.	GES	Class I	1993-02-18
K922903	Hygienex Examination Gloves	Hygienex Corp.	LYY	Class I	1993-02-18
K921889	Compel O and R	Standard Textile Co., Inc.	FYA	Class II	1993-02-18
K921549	Dornier Fibertome 100 Watt Surgical Laser	Dornier Medtech America, Inc.	GEX	Class II	1993-02-18
K930399	Orc Endoscopic Instrument Holder	O.R. Concepts, Inc.	MDM	Class I	1993-02-17
K926342	Vista(r) Human Chorionic Gonadotropin (Hcg) Assay	Syva Co.	JHI	Class II	1993-02-17
K925713	Vita Cerec Duo Cement	Vident	EMA	Class II	1993-02-17
K925542	Oxyshuttle II ,Modification	Sensor Medics Corp.	DQA	Class II	1993-02-17
K925438	Combination Trach Tie & Ventilator Antidisconnect	Aga Medical Products, Inc.	JOH	Class II	1993-02-17
K924138	Osteomed M3 System (Sbf System)	Osteomed	JEY	Class II	1993-02-17
K922754	Tandem-E Ige II Calibration Verification Set	Hybritech, Inc.	JJX	Class I	1993-02-17
K922027	Ambulatory (Holter) Recording, Modification	Biosensor Corp.	DSI	Class II	1993-02-17
K920574	Camsys 6300	F.M. Wiest USA, Inc.	EXQ	Class II	1993-02-17
K930028	Calmps: Bone, Mastin, Lewin, Brand	Thomasville Medical Assoc.	LXH	Class I	1993-02-16
K924905	Medi-Plinth	Medi-Man Rehabilitation Products, Inc.	INQ	Class I	1993-02-16
K924171	Lemaitre Retrograde Valvulotome	Vascutech, Inc.	MGZ	Class II	1993-02-16