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 1877 of 3531

510(k) clearances, page 1877 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K972141	The Yellow Iris Urinalysis Workstation	Intl. Remote Imaging Systems	KQO	Class I	1997-08-25
K972039	New Sound Hidden Aid Completely in Canal (Cic)	Nu-Sound	ESD	Class I	1997-08-25
K972023	Sleep-in Bone Screw System	Influence, Inc.	LRK	Class II	1997-08-25
K971973	Kodak Digital Science Pro-Medical Thermal Printer	Eastman Kodak Company	LLZ	Class II	1997-08-25
K971946	Npb-190 Pulse Oximeter (Npb-190)	Medtronic, Inc.	DQA	Class II	1997-08-25
K971938	Repicci II Unicondylar Knee	Zimmer GmbH	HRY	Class II	1997-08-25
K971397	Viewcath 3-D Catheter Pullback	Quinton, Inc.	ITX	Class II	1997-08-25
K971146	Laparette	Rd Chus, Inc.	KNF	Class II	1997-08-25
K971044	Dash, Sullivan, Vital Gard	Dash Medical Gloves, Inc.	LYY	Class I	1997-08-25
K970990	Gyrex Prima 1Tg 1.0T MRI System	Elscint Mr, Inc.	LNH	Class II	1997-08-25
K970686	Accutemp-Probe	Kentec Medical, LLC	FMT	Class II	1997-08-25
K970646	Safari	Ranger All Season Corp.	INI	Class II	1997-08-25
K970135	Nitrile Gloves	Sage Products LLC	LZC	Class I	1997-08-25
K972884	Accurun 146 Cmv Igm Positive Control	Boston Biomedica, Inc.	LKQ	Class II	1997-08-22
K972665	Chase Blood Vessel Shunt	Chase Medical, Inc.	DWF	Class II	1997-08-22
K972563	Lift Master	Mechanical Application Designs, Inc.	ITI	Class II	1997-08-22
K972443	Menicon Sf-P and Menicon Z Rigid Gas Permeable Contact Lens	Menicon U.S.A., Inc.	HQD	Class II	1997-08-22
K972095	Immulite 2000 Psa	Siemens Healthcare Diagnostics Inc.	LTJ	Class II	1997-08-22
K972043	Medtronic Model 3273/3274 RF Receiver and Model 3629/3630 Screener	Medtronic, Inc.	GZB	Class II	1997-08-22
K971956	Crt2000 Thermographic System	Werner Eidam Medizin-Technologie GmbH	LHQ	Class I	1997-08-22
K971117	Warmette	Olympic Medical Corp.	LHC	Class I	1997-08-22
K970891	Drape, Surgical-Latex	Protek Medical Products, Inc.	KKX	Class II	1997-08-22
K970675	Headloc Ceramic Head	Ortho Development Corp.	LZO	Class II	1997-08-22
K964562	Dtx-200 Bone Densitometer	Osteometer Meditech A/S	KGI	Class II	1997-08-22
K963899	Causse Universal Ossicular Replacement Prosthesis (Orp/1)	Exmoor Plastics Limited	ETA	Class II	1997-08-22
K972966	Axt 150M Manual Collimator (Axt 150M)	Applied X-Ray Technologies, Inc.	IZX	Class II	1997-08-21
K972646	Ad-Heal Hydrogel Dressing, Various Sizes	Ludlow Technical Products	NAE	Class I	1997-08-21
K972350	Model 50 Bipolar Coagulator	Boston Surgical Products, Inc.	GEI	Class II	1997-08-21
K972340	Insight 7000 Phased Array Torso Coil	GE Healthcare Coils	MOS	Class II	1997-08-21
K972061	Toa	W. Keith Thornton, D.D.S.	LRK	Class II	1997-08-21
K971903	Scanning Device Accessory for Use with the Cb Diode/532 Nd:yag Laser	Continuum Biomedical, Inc.	GEX	Class II	1997-08-21
K971509	Endoxane	Novatech S.A.	NWA	Class II	1997-08-21
K971475	Shielded Surgical Trocar	Ethicon Endo-Surgery Inc	GCJ	Class II	1997-08-21
K970196	T-Wall Uncuffed Tracheal Tube	Vital Signs, Inc.	BTR	Class II	1997-08-21
K965207	Rid-Decube II	Skin Care Management, Inc.	FNM	Class II	1997-08-21
K964907	Venomidicard Pediatric Venous Reservoir with Integralcardiotomy Filter/midicard Pediatric Cardiotomy Reservoir with Filt	Sorin Biomedical, Inc.	DTN	Class II	1997-08-21
K962577	Arrowgard Blue Quad-Lumen Central Venous Catheter	Arrow Intl., Inc.	FOZ	Class II	1997-08-21
K972673	Avl 9181 Electrolyte Analyzer	Avl Scientific Corp.	JFP	Class II	1997-08-20
K972619	Quickscreen One Step Opiate Screening Test (9080)	Phamatech Inc.	DJG	Class II	1997-08-20
K972577	Quick Screen One Step Amphetamine Test	Phamatech Inc.	DIT	Class II	1997-08-20
K972571	Quikstrip One Step Opiates Test	Drial Consultants, Inc.	DJG	Class II	1997-08-20
K972567	Pasco Mic and Mic/id Panels	Pasco Laboratories, Inc.	JWY	Class II	1997-08-20
K972449	Copan Venturi Transystem Amies Medium with Charcoal	Copan Italia	JSL	Class I	1997-08-20
K972448	Copan Venturi Transystem Amies Medium without Charcoal	Copan Italia	JSL	Class I	1997-08-20
K972427	Innerwear, Jimmy-O Raincoat, Raincoat, Jasmine, Drink	Custom Services Intl., Inc.	HIS	Class II	1997-08-20
K972310	Nihon Kohden Qp-932E ECG Exercise Test Option for the Nihon Kohden ECG-9320/A Cardiofax Electrocardiograph	Nihon Kohden America Inc	DPS	Class II	1997-08-20
K972308	Mednext 1000 Drill	Mednext, Inc.	GEY	Class I	1997-08-20
K972303	Oscular Sciences/ American Hydron, Inc Daily Wear Soft Contact Lens	Ocular Sciences Puerto Rico, Inc.	LPL	Class II	1997-08-20
K971970	Ebi Spinelink System	Electro-Biology, Inc.	MNH	Class II	1997-08-20
K971958	Synchron Lx Systems Transferrin (Trfn) Reagent	Beckman Instruments, Inc.	DDG	Class II	1997-08-20