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 2026-11-02, 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 2444 of 3531

510(k) clearances, page 2444 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K911718	M.a.r.a. (Modular Acetabular Reconstruction Syst)	Zimmer GmbH	JDI	Class II	1991-07-16
K911119	Sopur Gmbh Wheelchairs	Sopur GmbH	IOR	Class I	1991-07-16
K911069	Versa-Stim Electrode Line Modified	Conmedcorp	GXY	Class II	1991-07-16
K910936	Empty i.v. Container	Ellis Pharmaceutical Consulting, Inc.	KPE	Class II	1991-07-16
K910915	Patient Warmer Model 100C	Developmed Corp.	FMT	Class II	1991-07-16
K910418	Life-Trace Disposable Leg Plate Product # Lt-100	Graphic Controls Corp.	HGM	Class II	1991-07-16
K912649	Ise/k+	Boehringer Mannheim Corp.	CEM	Class II	1991-07-15
K911686	Global Total Shoulder, Uncement Humeral Hemi-Shoul	Depuy, Inc.	HSD	Class II	1991-07-15
K911685	Ranawat/burstein Porous Total Hip Femoral Comp	Zimmer GmbH	JDI	Class II	1991-07-15
K911564	E-Z Lift Imaging Table with Foot Pump	Med-Tron Products, Inc.	IYZ	Class I	1991-07-15
K911561	Xyz Imaging Table with Foot Pump	Med-Tron Products, Inc.	IYZ	Class I	1991-07-15
K911454	Fc2000	S & S Inficon, Inc.	JAA	Class II	1991-07-15
K910840	Vascular Biopsy Forceps	Vascular Products, Inc.	DWZ	Class II	1991-07-15
K910081	Tbd	Empi	KPI	Class II	1991-07-15
K905713	Bard Ambulatory Pump Tubing Set	C.R. Bard Inc	FRN	Class II	1991-07-15
K905578	Viewnet	Imagenet	LNH	Class II	1991-07-15
K911891	Fluidshield(tm) Cone Classic(tm) II Surgical Mask	Tecnol New Jersey Wound Care, Inc.	FXX	Class II	1991-07-12
K911678	Rotating Hemostatic Valve	Devices for Vascular Intervention, Inc.	DYB	Class II	1991-07-12
K911595	Infinity(tm) Porous-Coated Trochanteric Module	Dow Corning Wright	JDG	Class II	1991-07-12
K911295	Angioplasty Inflator	Vastek	MAV	Class II	1991-07-12
K911134	Surgical Gloves	Kenwell International, Ltd.	KGO	Class I	1991-07-12
K910958	Medflator Inflation System	Medex, Inc.	MAV	Class II	1991-07-12
K905778	Epidural Indication for Baxter Infusors Attachment	Baxter Healthcare Corporation	FRN	Class II	1991-07-12
K912605	Amcath Disposable Micro Scissors	Intl. Medical, Inc.	GCJ	Class II	1991-07-11
K911738	Medical Assemblies Filter	Medical Assemblies, Inc.	CAH	Class II	1991-07-11
K911737	Medical Assemblies Mass Spect Monit Line/connect	Medical Assemblies, Inc.	CCK	Class II	1991-07-11
K911736	Medical Assemblies Adult Anesthesia Breath Circuit	Medical Assemblies, Inc.	CAI	Class I	1991-07-11
K911657	Fetal Scalp Spiral Electrode	Advanced Medical Systems, Inc.	HGP	Class II	1991-07-11
K911648	Redfield Infrared Coagulator	Redfield Corp.	KNS	Class II	1991-07-11
K910795	Comfor-Dent Denture Liner	Comfort Acrylics, Inc.	EBI	Class II	1991-07-11
K910745	Hemoglobin Reagent	Toa Medical Electronics USA, Inc.	GKR	Class II	1991-07-11
K910429	Swan-Ganz Flow Directed Pressure Td Catheter	Baxter Healthcare Corporation	DXO	Class II	1991-07-11
K910212	Color Doppler Option to Ai 5200 Diag Ultraso Syst	Acoustic Imaging Technologies Corp.	JYO	Class I	1991-07-11
K904632	Centauri Yag Laser Syst, Gynecology	Pfizer Laser Systems	GEX	Class II	1991-07-11
K911671	Ceradelta	Metalor Dental USA Corp.	EJS	Class II	1991-07-10
K911616	Horizon Xl	Mennen Medical, Inc.	DRT	Class II	1991-07-10
K904432	Sleep I/t-5 and Sleep I/t-8	Cns, Inc.	BZQ	Class II	1991-07-10
K903174	Advance Suture Absorbable Gut Suture	Advance Suture, Inc.	GAE	Class I	1991-07-10
K912357	3K-Cal Hematology Calibrator/multiple	R & D Systems, Inc.	KRX	Class II	1991-07-09
K912207	Fx-Cablelok System	Biodynamic Technologies, Inc.	JDQ	Class II	1991-07-09
K912071	Space(tm) 7500	F.M. Wiest USA, Inc.	IKN	Class II	1991-07-09
K911793	Coulterclone	Coulter Immunology	GKZ	Class II	1991-07-09
K911643	Abiodent Periotemp(r) System	Abiomed, Inc.	EIL	Class I	1991-07-09
K911632	Capiox(r) Bubble Trap	Terumo Medical Corp.	KRL	Class II	1991-07-09
K911606	Baxter Preoperative Skin Prep Tray W/foam Sponges	Baxter Healthcare Corporation	KDD	Class I	1991-07-09
K911605	Tracker Unibody, Unibody W/side & 25 Side Holes	Target Therapeutics	DQO	Class II	1991-07-09
K911600	Ilco Infrared Light Coagulator	Holl Meditronics, Inc.	KNS	Class II	1991-07-09
K911183	Nhs 2044P Body Aid, Hearing Aid	Magnatone Hearing Aid Corp.	ESD	Class I	1991-07-09
K910827	Abl520 Blood Gas System	Radiometer America, Inc	GHS	Class II	1991-07-09
K910610	Interplak Home Plaque Removal Instrument	Bausch & Lomb Incorporated	JEQ	Class I	1991-07-09