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 1509 of 3531

510(k) clearances, page 1509 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K022960	Ge Quasar Nuclear Medicine System	GE Medical Systems F.I. Haifa	KPS	Class II	2002-09-19
K022919	Smart Breath Respiratory Compensation Option	GE Healthcare	JAK	Class II	2002-09-19
K022859	Abutment and Prosthetic Accessories to the Iti Dental Implant System	Straumann USA, LLC	DZE	Class II	2002-09-19
K022857	Pump Tubing with X-Coating	Terumo Cardiovascular Systems Corporation	DWE	Class II	2002-09-19
K022806	Duopro Safety Syringe (Duopross)	MK Meditech	MEG	Class II	2002-09-19
K022786	Dvt60	Huntleigh Healthcare Ltd.	JOW	Class II	2002-09-19
K022387	Craftmatic Adjustable Beds with Optional Heat & Massage, Models Craftmatic Monaco, I, II, III & Classic	Craftmatic Organization, Inc.	LLI	Class II	2002-09-19
K022363	Sjm Tailor Annuloplasty Band, Model Tab-(Size) (Tailor Band)	Abbott Medical	KRH	Class II	2002-09-19
K022318	Vomed Endoscopic and Urological Accessories	Vomed Volzer Medizintechnik GmbH & Co.	HIF	Class II	2002-09-19
K022252	Sterngold 1, Model 1127781	Sterngold	EJS	Class II	2002-09-19
K022196	Natus Blue Light Phototherapy Unit	Bio-Logic Systems Corp.	LBI	Class II	2002-09-19
K022132	Servo Ventilator System, Model 64 87 800 E407e	Siemens Medical Solutions USA, Inc.	CBK	Class II	2002-09-19
K022113	3I Dental Implant Accessories	ZimVie US Corp LLC	DZE	Class II	2002-09-19
K022075	Disposable Temporary Pacing Cable,models Cpw-Bv-5,Cpw-Lg-5,Cpw-Sm-5,Cpw-Era300-5,Cpw-Qloc-5	Cp Medical	DSA	Class II	2002-09-19
K021698	My Allergy Test	Immunetech Corporation	JKA	Class II	2002-09-19
K021649	Binax Now Flu a Test (27 Test), Binax Now Nasopharyngeal Swab Specimen Accesory Pack	Binax, Inc.	PSZ	Class II	2002-09-19
K021646	Binax Now Flu B Test (27 Test), Binax Now Nasopharyngeal Swab Specimen Accesory Pack	Binax, Inc.	PSZ	Class II	2002-09-19
K022778	Modification to Tsrh Spinal System	Medtronic Sofamor Danek	MNI	Class II	2002-09-18
K022744	Reprocessed Used Disposable Arthroscopic Blades and Burs	Medical Device Services	HWE	Class I	2002-09-18
K022470	Porta Solder 1080 W	Wieland Dental + Technik GmbH & Co. KG	EJT	Class II	2002-09-18
K022469	Eco E4	Wieland Dental + Technik GmbH & Co. KG	EJS	Class II	2002-09-18
K022462	Bioporta Solder 1020	Wieland Dental + Technik GmbH & Co. KG	EJT	Class II	2002-09-18
K022224	Cool Bond Light Cured Bracket Adhesive System	Coltene, Inc.	DYH	Class II	2002-09-18
K020581	Coloshield Colonoscopy Drape Model E2000	Medical Concepts Development, Inc.	KKX	Class II	2002-09-18
K020255	Riwo Net Operating Operating Control System, Model #5590	Richard Wolf Medical Instruments Corp.	ODA	Class II	2002-09-18
K013280	Sterilox Liquid Chemical Sterilant System	Sterilox Technologies, Inc.	MED	Class II	2002-09-18
K022991	Liquichek Immunology Control Level 1, 2, and 3-1 Ml, Model 591, 592, 593; Level 1, 2, and 3-3 Ml, Model 594, 595, 596	Bio-Rad	JJY	Class I	2002-09-17
K022920	M2376a Devicelink System	Philips North America LLC	MWI	Class II	2002-09-17
K022878	Brightway Brand Colored Powder Free Nitrile Examination Gloves (Orange)	Brightway Holdings Sdn. Bhd.	LZA	Class I	2002-09-17
K022874	Gen-Probe Aptima Combo 2 Assay	Hologic, Inc.	JTW	Class I	2002-09-17
K022818	Multiple, Blue Powder Free Nitrile Examination Gloves with Peppermint Flavor	Smart Glove Corp. Sdn Bhd	LZA	Class I	2002-09-17
K022772	Raichem Ldl-Cholesterol Direct Reagent	Hemagen Diagnostics, Inc.	MRR	Class I	2002-09-17
K022758	Linical Hscrp Calibration Verifiers Levels a-E for the Dade Bn II Nephelometer	Cliniqa Corporation	JJX	Class I	2002-09-17
K022701	Powder-Free, Latex Examination Glove Coated with Aloe Vera Gel and Vitamin E	Perusahaan Getah Asas Sdn. Bhd.	LYY	Class I	2002-09-17
K022515	Biomet Calcaneal Plate	Biomet Orthopedics, Inc.	HRS	Class II	2002-09-17
K022468	Porta Optimum Solder 900	Wieland Dental + Technik GmbH & Co. KG	EJT	Class II	2002-09-17
K022467	Porta Ip Solder V-2	Wieland Dental + Technik GmbH & Co. KG	EJT	Class II	2002-09-17
K022457	Porta Optimum Solder 710	Wieland Dental + Technik GmbH & Co. KG	EJT	Class II	2002-09-17
K022456	Porta Ip Solder V-1	Wieland Dental + Technik GmbH & Co. KG	EJT	Class II	2002-09-17
K022444	Powder Free Green Neoprene Surgical Gloves, Sterile with Aloe Vera	WRP Asia Pacific Sdn Bhd	KGO	Class I	2002-09-17
K022423	External Fixation Ring	Rigid FX Orthopedics, Incorporated	KTT	Class II	2002-09-17
K022386	Pocketchem Ua Aution Sticks 10Ta	Arkray, Inc.	JIL	Class II	2002-09-17
K022324	Normed Titanium Calcaneus Plating with Locking Screw System	Osteomedics, Inc.	HRS	Class II	2002-09-17
K022163	Welch Allyn Spot Vital Sign Monitor with Mp506	Welch Allyn Inc	DQA	Class II	2002-09-17
K022114	Imperium	Elmstech, Inc.	OWB	Class II	2002-09-17
K022069	Oec Fluorotrak 9800 Plus	GE Healthcare	OWB	Class II	2002-09-17
K021761	Premier Anterior Cervical Plate System	Medtronic Sofamor Danek	KWQ	Class II	2002-09-17
K021057	Brahms Diagnostica Dynotest Tg-Plus	Brahms Diagnostica, LLC	MSW	Class II	2002-09-17
K020583	IVD Giardia Antigen Detection Assay Model Gl-96	IVD Research, LLC.	MHI	Class II	2002-09-17
K020464	Sanidad Far-Infrared Mini Lamp, Model Fi-3646	Rolor Electronics Corp.	ILY	Class II	2002-09-17