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 1810 of 3531

510(k) clearances, page 1810 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K981182	Osteograf/n-300	Ceramed Dental, LLC	LYC	Class II	1998-07-02
K974868	Sigma Plus Monoplace Hyperbaric Chamber	Perry Baromedical Corporation	CBF	Class II	1998-07-02
K973363	North American Scientific(nasi)pd-103 Radionuclide Brachytherapy Source-Model Med3633	Ml Strategies, Inc.	IWI	Class II	1998-07-02
K981598	Hernia Mesh Stabilizer	Medivices Co.	GCJ	Class II	1998-07-01
K981486	Stair-Lift	Garaventa (Canada) Ltd.	ING	Class II	1998-07-01
K981247	Silcast (Code Name Rd-0118)	J.F. Jelenko & Co., Inc.	EJS	Class II	1998-07-01
K981215	Psi-Tec Liposuction Aspirator	Byron Medical	QPB	Class II	1998-07-01
K981213	Universal Instrument Registration (Uir) Microscope Module I	Radionics, Inc.	HAW	Class II	1998-07-01
K981187	Acl Avulsion Lag Screw with Sheath Model Number Ar-6001	Arthrex GmbH	HWC	Class II	1998-07-01
K980913	Cryo-Hit Model Numbers Ep3t3, Ep5t2, Ep5t5, Ep7t5, Ep8t5	Galil Medical Ltd.	GEI	Class II	1998-07-01
K980087	Presdure Products Pressure Pads, Models P100, P110, P120, P130, P200, P210, P220, P230, P300, P310, P320, P330	Pressure Products, Inc.	DXC	Class II	1998-07-01
K974739	Hakim Programmable Valve System	Johnson & Johnson Professionals, Inc.	JXG	Class II	1998-07-01
K971975	Cardima Pathfinder 1.5F Mapping Microcatheter	Cardima, Inc.	DRF	Class II	1998-07-01
K981753	Innovative Technologies Transparent Film and Intelligent Film Wound Dressing	Innovative Technologies, Ltd.	MGP	Unclassified	1998-06-30
K981717	Stryker Knifelight, Stryker Illuminated Retractor	Stryker Corp.	FTD	Class II	1998-06-30
K981714	Timx Low Back System Titanium Mx Rod Based Low Back System	Acromed Corp.	MNH	Class II	1998-06-30
K981410	Hammersmith Endocavitary Coils	Philips North America LLC	LNH	Class II	1998-06-30
K981293	7200 Ultrasound Imaging System	Esaote North America, Inc	IYO	Class II	1998-06-30
K981227	Symphony 360 Remote Control Table	Acoma Medical Imaging, Inc.	JAA	Class II	1998-06-30
K981194	Futura Biomedical Flexible Great Toe Implant	Nexa Orthopedics, Inc.	KWH	Class II	1998-06-30
K981190	High Impedance Cardiac Gating Cable	GE Healthcare	LNH	Class II	1998-06-30
K981172	Lipoplasty/ Liposuction Aspiration and Tumescent Infusion Cannulae and Needles	Byron Medical	QPB	Class II	1998-06-30
K981121	Amigo Rt	Amigo Mobility Intl., Inc.	INI	Class II	1998-06-30
K980362	MRI Compatible Monitor and Accessories	Datex-Engstrom, Inc.	DPS	Class II	1998-06-30
K973914	Sense Technology Inc. Fras, Sense Technology Inc. Pulstar	Sense Technology, Inc.	LXM	Unclassified	1998-06-30
K982071	I-Stat Lactate Test	I-Stat Corp.	KHP	Class I	1998-06-29
K982024	Opiates 2000 Liquid Opiates Drugs of Abuse Control Levels 2 and 3	Medical Analysis Systems, Inc.	DIF	Class I	1998-06-29
K981933	Urichemtrak Liquid Assayed Control Levels 1 and 2	Medical Analysis Systems, Inc.	JJW	Class I	1998-06-29
K981906	Modification for Pta Balloon Catheter	Cook Inc.	LIT	Class II	1998-06-29
K981872	Salicylate-Sl Assay Catalogue Number 511-20,511-40	Sekisui Diagnostics P.E.I. Inc.	DKJ	Class II	1998-06-29
K981843	Ast	Abbott Medical	CIT	Class II	1998-06-29
K981769	Hichem Phosphorus Reagent Kit	Elan Pharma, Inc.	CEO	Class I	1998-06-29
K981652	Chol	Abbott Medical	CHH	Class I	1998-06-29
K981650	Ast/sgot Liquid Reagent - Kinetic Method	Teco Diagnostics	CIT	Class II	1998-06-29
K981536	Quantech Myoglobin Assay	Hellen Professional Services	MVE	Class II	1998-06-29
K981386	Manan Blunt Needle	Argon Medical Devices, Inc	FPA	Class II	1998-06-29
K981362	Synthes (USA) External Multi Vector Mandible Distractor	Synthes (USA) Products LLC	DZL	Class II	1998-06-29
K981342	Abbott Cell-Dyn 4000 Immunopit (Cd61) Assay	Abbott Medical	GKZ	Class II	1998-06-29
K981320	Daum Bone Biopsy Set	Daum Corp.	KNW	Class II	1998-06-29
K981291	Vantage 3.0 Insynch	Philips North America LLC	KPS	Class II	1998-06-29
K981243	Biostride Free T4 Eia Test Kit	Biostride Diagnostics, Inc.	CEC	Class II	1998-06-29
K981219	Oscar Bipolar Scissors and Oscar Bipolar Reusable Cartridges	Enable Medical Corp.	GEI	Class II	1998-06-29
K981149	Lasette Laser Skin Perforator	Cell Robotics, Inc.	GEX	Class II	1998-06-29
K980915	Valleylab Optimumm Smoke Evacuator System	Medtronic, Inc.	FYD	Class II	1998-06-29
K980887	Elecsys Cea on the Elecsys 1010	Boehringer Mannheim Corp.	DHX	Class II	1998-06-29
K980836	Genie Cup Integrated Screening Device	Applied Technology Ventures, LLC	LDJ	Class II	1998-06-29
K980753	Chromoscan Scanning System	Mehl/Biophile Intl., Inc.	GEX	Class II	1998-06-29
K980170	Surgitron	Ellman Intl., Inc.	GEI	Class II	1998-06-29
K974879	Model 7410 Voyager	Healthdyne Technologies, Inc.	BZD	Class II	1998-06-29
K965223	Resolve Option for the Oracle in Vision Intravascular Ultrasonic Imaging System	Endosonics Corp.	IYO	Class II	1998-06-29