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 2214 of 3531

510(k) clearances, page 2214 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K922519	Mod. Percutaneous Arthroscopic Micro Discectomy	Smith & Nephew, Inc.	HRX	Class II	1994-03-29
K940855	Aurium Sg (High Gold Crown and Bridge Alloy)	Argen Precious Metals, Inc.	EJT	Class II	1994-03-28
K940788	Aurium 830	Argen Precious Metals, Inc.	EJT	Class II	1994-03-28
K940787	Aurium B4	Argen Precious Metals, Inc.	EJT	Class II	1994-03-28
K940779	Aurium D4	Argen Precious Metals, Inc.	EJT	Class II	1994-03-28
K940761	Aurium 22Kt	Argen Precious Metals, Inc.	EJT	Class II	1994-03-28
K940749	Lpg 5/10, Lpg 10/5, Lpg 10/15 and Lpg 15/10	Aalba Dent, Inc.	EJH	Class II	1994-03-28
K940439	Gleeson Flovac Handcontrolled Suction Irrigation Instrument	Conmedcorp	GCJ	Class II	1994-03-28
K940402	Supergel/suppressed Dust	Harry J. Bosworth Co.	ELW	Class II	1994-03-28
K940293	1.2 Micron Final Filter with Extension Tube	Puritas Health Care, Inc.	FPB	Class II	1994-03-28
K940258	Solution Transfer Container W/attached Leg Set (Empty)	Incutech, Inc.	KPE	Class II	1994-03-28
K940053	Infusion Administration Set	Puritas Health Care, Inc.	FPA	Class II	1994-03-28
K940051	Action Storm Power Wheelchair	Invacare GmbH	ITI	Class II	1994-03-28
K936235	Needlesafe II & Needlegard II	Ingenious Technologies Corp.	FMI	Class II	1994-03-28
K936168	Wilson-Cook Balloon Inflation Device	Wilson-Cook Medical Inc.	KNT	Class II	1994-03-28
K935410	Hoveround Mpv	Hoveround Corp.	ITI	Class II	1994-03-28
K935317	Alpha Talker	Prentke Romich Co.	ITI	Class II	1994-03-28
K935111	Unipowerr Rechargeable Battery Pack	Unipower Corp.	LDD	Class II	1994-03-28
K935069	Il1430 Bgelectrolyte Analyzer	Instrumentation Laboratory Co.	CHL	Class II	1994-03-28
K934969	Dualgard Face Shield	White Knight Healthcare	FXX	Class II	1994-03-28
K934744	Midmark Magnum General Surgical Table	Midmark Corp	GDC	Class I	1994-03-28
K934731	Medsurg Sterile Imaging Products	Medsurg Industries, Inc.	FMP	Class I	1994-03-28
K934607	Alko Reagents for Baxter Paramax Chemistry System	Alko Diagnostic Corp.	JIX	Class II	1994-03-28
K934256	Global Medical Cutting Biopsy Needle	Global Medical Prods, Inc.	FCG	Class II	1994-03-28
K934194	Barrier Laser Plus Face Mask	Johnson & Johnson MEDICAL GmbH	FXX	Class II	1994-03-28
K934188	Deroyal Surg Disp/reusable Skin Stapler Handle/cart	DeRoyal Industries, Inc.	GAG	Class II	1994-03-28
K934105	Dispos/reusable Surg Skin/stainless Steel Staples	Surgical Innovations Ltd	GAG	Class II	1994-03-28
K933864	720 Power Base	Fortress Scientific, Ltd.	ITI	Class II	1994-03-28
K933863	S500 Seating System	Fortress Scientific, Ltd.	ITI	Class II	1994-03-28
K933861	S860 Seating System	Fortress Scientific, Ltd.	ITI	Class II	1994-03-28
K933860	S480 Seating System	Fortress Scientific, Ltd.	ITI	Class II	1994-03-28
K933859	Sc930 Seat Controller	Fortress Scientific, Ltd.	ITI	Class II	1994-03-28
K933858	730 Power Base	Fortress Scientific, Ltd.	ITI	Class II	1994-03-28
K933856	A921 12 Volt Power Socket	Fortress Scientific, Ltd.	ITI	Class II	1994-03-28
K933855	S490 Seating System	Fortress Scientific, Ltd.	ITI	Class II	1994-03-28
K933854	770 Power Base	Fortress Scientific, Ltd.	ITI	Class II	1994-03-28
K933853	A901 Tilt in Space	Fortress Scientific, Ltd.	ITI	Class II	1994-03-28
K933600	Navarre Biomedical Tip-Locking Drainage Catheters	Navarre Biomedical, Ltd.	GBX	Class I	1994-03-28
K933326	Lifecare Plumset Vented Secondary i.v. Set	Abbott Medical	FPA	Class II	1994-03-28
K933232	Boehringer Laboratories Suction Regulator, Modified	Boehringer Laboratories, LLC	KDP	Class II	1994-03-28
K933207	Walkertalker	Prentke Romich Co.	ITI	Class II	1994-03-28
K933109	4Sure Uro-Link Urological Procedure Trays	Boston Pacific Medical, Inc.	KOD	Class II	1994-03-28
K932893	Vident 500 Alloy and Vident 550 Be Alloy	Vident	EJH	Class II	1994-03-28
K932786	Ucs 1000(Tm) with Tonguetouch Keypad Wheelchair	New Abilities Systems, Inc.	ITI	Class II	1994-03-28
K932597	Fortress C-300 Microprocessor Controller	Fortress Scientific, Ltd.	ITI	Class II	1994-03-28
K932329	Hoveround Power Chair	Hoveround Corp.	ITI	Class II	1994-03-28
K931798	Patient Examination Gloves	Graintrade, Ltd.	LYY	Class I	1994-03-28
K931640	Ao11 Body Massager	Fairform Mfg., Co., Ltd	IRO	Class I	1994-03-28
K931639	F183 Ac-Mini Massager with Ul Aproved Adaptor	Fairform Mfg., Co., Ltd	IRO	Class I	1994-03-28
K931638	Fo96 Handy Massager	Fairform Mfg., Co., Ltd	IRO	Class I	1994-03-28