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 1834 of 3531

510(k) clearances, page 1834 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K974192	Biosensor Holter Monitor System	Biosensor Corp.	DQK	Class II	1998-03-04
K973802	Shimasonic Linear/convex Diagnostic Ultrasound System	Shimadzu Medical Systems	IYO	Class II	1998-03-04
K973282	Handi Oxygen Analyzer	Ceramatec, Inc.	CCL	Class II	1998-03-04
K972591	Hydragel Bence Jones Kit/maxi Kit Hydragel Bence Jones/hydragel 2/4 Bence Jones Kit	Morax	JKM	Class II	1998-03-04
K972500	Tir/tij and Polyrox	BIOTRONIK AG	DTB	Class III	1998-03-04
K971840	Omni-Trak Model 3150 Series Patient Monitoring System	Invivo Research, Inc.	MHX	Class II	1998-03-04
K980528	Chiron Diagnostics Acs:180 Troponin I Assay (Ctni)	Chiron Diagnostics Corp.	MMI	Class II	1998-03-03
K980414	Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer Brand Blood Collection Set	BD Becton Dickinson Vacutainer Systems Preanalytic	JKA	Class II	1998-03-03
K980381	Phaseal, Closed System Forhandling of Parenteral Drugs, Additional Administration Devices. C80 Infusion Adapter, A10 Pro	Carmel Pharma AB.	LHI	Class II	1998-03-03
K980349	Quickpac II One Step Barbiturate Test	Syntron Bioresearch, Inc.	DIS	Class II	1998-03-03
K980141	Spectrum Designs Projection Malar Implant	Spectrum Designs, Inc.	LZK	Class II	1998-03-03
K980140	Spectrum Designs Medial Malar Implant	Spectrum Designs, Inc.	LZK	Class II	1998-03-03
K980139	Spectrum Designs Profile Malar Implant	Spectrum Designs, Inc.	LZK	Class II	1998-03-03
K980031	Acetaminophen Assay (Ace), Catalogue Number 503-10	Sekisui Diagnostics P.E.I. Inc.	LDP	Class II	1998-03-03
K974786	Prepquick	Ultradent Products Inc.	KLE	Class II	1998-03-03
K974752	Imtec/biobarrier Membrane	Imtec Corp.	NPK	Class II	1998-03-03
K974721	Unconjugated Estriol Assay for the Bayer Immuno 1 System (in Vitro Diagnostic System)	Bayer Corp.	CGI	Class I	1998-03-03
K974694	Is-Dsdna Test System	Diamedix Corp.	LRM	Class II	1998-03-03
K974555	Synthes 2.0 Mm Locking Plate System (2.0 Lps)	Synthes (USA) Products LLC	JEY	Class II	1998-03-03
K974538	Meniscal Repair Device	Linvatec Corporation	HWC	Class II	1998-03-03
K974084	Getinge/castle Optiview Series Surgical Light	Getinge/Castle, Inc.	FSY	Class II	1998-03-03
K973523	Accustat H. Pylori One Step Test	Boehringer Mannheim Corp.	LYR	Class I	1998-03-03
K971522	Abbott Testpack Plus Strep a with on Board Controls (Obc) II	Abbott Medical	GTZ	Class I	1998-03-03
K962903	Prestige Medical Series 2100 Clinical Autoclave	Prestige Medical, Ltd.	FLE	Class II	1998-03-03
K980093	Disposable Synthetic Patient Exmination Gloves, Powder Free	Universal Gloves Corp.	LYZ	Class I	1998-03-02
K980061	Embryon Intrauterine Insemination Catheter, Emryon Soft Intrauterine Insemination Catheter, Stylet for Embryon Intrauter	Rocket Medical	MFD	Class II	1998-03-02
K980032	Salicylate Assay (Ace), Catalogue Number 501-71	Sekisui Diagnostics P.E.I. Inc.	DKJ	Class II	1998-03-02
K974724	Softmate Automatic Lens Cleaning Unit, Clensatron 700 Cl Automatic Contact Lens Cleaner, Visonic Dome, Lensonic Contact	Lens Comfort, Inc.	LYL	Class II	1998-03-02
K974599	Ultravue/p, Ultralvue/c (Hioxifilcon B)) Soft (Multifocal) Daily Wear Contact Lens (Clear & Yinted, Lathe-Cut from Lens)	Opti-Centre Laboratories	LPL	Class II	1998-03-02
K974563	Colpo Cup Cvc-2000	Clinical Innovations, LLC	HDP	Class II	1998-03-02
K974525	Synthes Spine Anterior Thoracolumbar Rod Clamp (Atrc) System	Synthes GmbH	KWQ	Class II	1998-03-02
K974475	Theraport Low-Profile Vascular Access System Models 1011 and 1012	Biocontrol Technology, Inc.	LJT	Class II	1998-03-02
K974313	Hydrofera Surgical Spear	Hydrofera, LLC.	HOZ	Class II	1998-03-02
K974034	Portable Intensive Care Unit	Medical Research Laboratories, Inc.	DRO	Class II	1998-03-02
K973357	Coonrad/morrey Total Elbow, New Hinge Pin	Zimmer GmbH	JDC	Class II	1998-03-02
K973108	Total Protein (Micro) Assay, Catalogue Number 450-50	Sekisui Diagnostics P.E.I. Inc.	CEK	Class II	1998-03-02
K972324	Leksell Stereotactic System	Elekta Instrument AB	HAW	Class II	1998-03-02
K971759	Medport Emergency Medication Airway Tube Adapter	Green Field Medical Sourcing, Inc.	BTR	Class II	1998-03-02
K971028	Worlds Best Brand Non-Lubricated, Worlds Best Brand Lubricated	Worlds-Best Gummivarefabrik A/S	HIS	Class II	1998-03-02
K980418	Benz Methafilcon a Optical Blank, Benz Methafilcon a Spherical and Toric Soft (Hydrophilic) Contact Lenses for Daily Wer	Benz Research and Development LLC	LPL	Class II	1998-02-27
K980366	Aaron 1200 High Frequency Electrosurgicl Generator A1200, A1200/240	Apyx Medical Corporation	GEI	Class II	1998-02-27
K980281	Welch Allyn Xenon 300 Light Source	Welch Allyn Inc	GCT	Class II	1998-02-27
K980229	Msb TENS Electrodes (Disposable)	Msb, Ltd.	GXY	Class II	1998-02-27
K980171	Dermasense Plus Dispersive Electrode	Horizon Medical, Inc.	GEI	Class II	1998-02-27
K980156	Slt Select Fiber Delivery System and Contact Tips	Surgical Laser Technologies, Inc.	GEX	Class II	1998-02-27
K980050	Mentor Skin Protection Pad	Mentor	GCJ	Class II	1998-02-27
K974900	Cynosure Photogenica 532 Laser	Cynosure, LLC	GEX	Class II	1998-02-27
K974857	4.0Mm Simpler Threaded Dental Implant	Vancouver Implant Resources, Inc.	DZE	Class II	1998-02-27
K974856	3.25Mm Simpler Threaded Dental Implant	Vancouver Implant Resources, Inc.	DZE	Class II	1998-02-27
K974570	Peritoneal Dialysis Catheter Connector	Medigroup	FKO	Class II	1998-02-27