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 1807 of 3531

510(k) clearances, page 1807 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K981424	Nomos Bat Ultrasound Localization and Positioning System	Nomos Corp.	IYE	Class II	1998-07-17
K981417	Squirt Fluid Delivery System	Merit Medical Systems, Inc.	QEY	Class II	1998-07-17
K980778	Hakim Micro Programmable Valve System	Johnson & Johnson Professionals, Inc.	JXG	Class II	1998-07-17
K980670	Cms Blizzard 700 Series Models 710, 711, 712, 720, 721 and 722	Cryomedical Sciences, Inc.	GEH	Class II	1998-07-17
K980668	Cms Blizzard 700 Series Models 730, 740,750,760,770,780 & 790	Cryomedical Sciences, Inc.	GEH	Class II	1998-07-17
K980185	Colorpac Toxin a	BD Becton Dickinson Vacutainer Systems Preanalytic	LLH	Class I	1998-07-17
K973430	Kodak Pro-Medical Digital Camera System	Eastman Kodak Company	GCJ	Class II	1998-07-17
K972846	Bmc RF Cannula	Baylis Medical Co., Inc.	GXI	Class II	1998-07-17
K972575	800 Series Surgical Laser System Orion Series Surgical Laser System Angled Delivery Devices	Laserscope	GEX	Class II	1998-07-17
K970069	Dual Hook Fiberoptic Delivery System	Ihd, Inc.	GEX	Class II	1998-07-17
DEN980003	Diamond Probe/perio 2000 System	Diamond General Development Corp.	MVH	Class II	1998-07-17
K981414	Lc Positioner	Fischer Imaging Corp.	JAA	Class II	1998-07-16
K981406	Cervix Coil Latex Sheath	Philips North America LLC	MOS	Class II	1998-07-16
K981405	Synergy Lt	Oxford Instruments, PLC.	GWF	Class II	1998-07-16
K980920	Equinoxe	Bouvier Hydro, Inc.	ILJ	Class II	1998-07-16
K980879	Oscillomate Nibp / Sp02 Ems Monitor	Cas Medical Systems, Inc.	DQA	Class II	1998-07-16
K980066	CPR Filtershield	Plasco, Inc.	BTM	Class II	1998-07-16
K973004	Knightstar 335	Medtronic, Inc.	MNT	Class II	1998-07-16
K972700	Exmoor Attic and Mastoid Antrum Middle Ear Implant (Emmett Campbell Md Facs Pattern)	Exmoor Plastics Limited	KHJ	Class II	1998-07-16
K981619	Vacuette Multiple Sample Luer Adapter	Greiner Meditech, Inc.	FMI	Class II	1998-07-15
K981575	Tympanostomy Tube	Grace Medical, Inc.	ETD	Class II	1998-07-15
K981546	Nti Clenching Suppression System	Kulzer GmbH	MQC	Unclassified	1998-07-15
K981533	Aviva Systems Model Numbers 1010, 2020	American Telecare, Inc.	DRG	Class II	1998-07-15
K981381	Acs Hi-Torque Cross-It Guide Wire with Hydrocoat Hydrophilic Coating Product Family Models 1003211H,1003212hj,1003213h,1	Boston Scientific Corporation	DQX	Class II	1998-07-15
K981235	Oculostat	Laser Center Dev. Corp.	HNC	Class I	1998-07-15
K974736	Heartport Direct Aortic Return Cannula with Introducer	Heartport, Inc.	DWF	Class II	1998-07-15
K974586	Aurora Diode Laser System	Premier Laser Systems, Inc.	GEX	Class II	1998-07-15
K972728	Sterile Water for Injection Prefilled Syring (Swfips)	BD Becton Dickinson Vacutainer Systems Preanalytic	FMF	Class II	1998-07-15
K972538	Flow-Eze Blunt Cannula (1999Bc)	Acacia, Inc.	FMI	Class II	1998-07-15
K982250	Access Free T4 Reagents on the Access Immunoassay Analyzer	Beckman Instruments, Inc.	CEC	Class II	1998-07-14
K982203	Caas II Lva Biplane Option	Pie Medical Equipment B.V.	IZI	Class II	1998-07-14
K982049	Biopsy M	Sitco, Inc.	IZH	Class II	1998-07-14
K982028	Fluorospot Compact	Siemens Medical Solutions USA, Inc.	JAA	Class II	1998-07-14
K981899	Careside Hdl-Cholesterol	Exigent Diagnostics, Inc.	LBS	Class I	1998-07-14
K981475	Opart (Mrt-600) Versions 2 Software Upgrade	Toshiba America Mri, Inc.	LNH	Class II	1998-07-14
K981466	Xr-910	Dental Imaging Technologies Corporation	IZL	Class II	1998-07-14
K981459	Membrane Tack	Zimmer GmbH	DZL	Class II	1998-07-14
K981415	0-20 Cm H20 PEEP Valve	Cheen Houng Ent. Co. Ltd.	BYE	Class II	1998-07-14
K981391	Par-One	Remel Inc	LIO	Class I	1998-07-14
K981266	Auto-Injector, Sure-Inject 2000	Mighty Mo, Corp.	KZH	Class II	1998-07-14
K974730	Softrans Plus Intrauterine Pressure Catheter System (Iup 5000, Softrans Plus Iupc)	Graphic Controls Corp.	KXO	Class II	1998-07-14
K974457	Scout 3.2/45 Mhz Coronary Imaging Catheter, Scout 3.2/45 Mhz Coronary Imaging Catheter, Scout Imaging Catheter Patient T	Hewlett-Packard Co.	IYO	Class II	1998-07-14
K974040	C3 External Male Bladder Control Device	Timm Research Co.	FHA	Class I	1998-07-14
K982293	Pressure Transducer Airflow Sensor	Pro-Tech Services, Inc.	MNR	Class II	1998-07-13
K982154	Modification of Townley Pedicle Screw Plating System	Danek Medical, Inc.	MNI	Class II	1998-07-13
K982067	Magnetic Port Silicone Tissue Expander	Specialty Surgical Products, Inc.	LCJ	Unclassified	1998-07-13
K981798	Lactosorb Pop Rivet	Zimmer GmbH	JDR	Class II	1998-07-13
K981789	Lorenz Pectus Support Bar Stabilizer	Biomet Microfixation	HRS	Class II	1998-07-13
K981764	Lm Anchor	Li Medical Technologies, Inc.	MBI	Class II	1998-07-13
K981755	Lm Anchor	Li Medical Technologies, Inc.	MBI	Class II	1998-07-13