510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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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 , 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
YearClearances
20123,135
20133,052
20143,202
20153,020
20162,956
20173,200
20183,062
20192,918
20202,923
20213,023
20223,209
20233,346
20243,129
20253,225
20262,732
176,529 records, page 1941 of 3531
510(k) clearances, page 1941 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K963723Laceration TrayGrand Medical ProductsLRPClass I
K963722IV Start KitGrand Medical ProductsLRSClass II
K963721Skin Scrub TrayGrand Medical ProductsLROClass II
K963720Tracheostomy KitGrand Medical ProductsLRQClass I
K963719Central Line Dressing Change Tray, Tpn/cvp Dressing Change TrayGrand Medical ProductsMCYClass II
K963715Debridement Tray, Incision and Drainage TrayGrand Medical ProductsLROClass II
K963714Grand Medical Suture Removal KitGrand Medical ProductsMCZClass I
K963697Advanced Diagnostic Viewer (Adv)Bio-Vascular, Inc.LLZClass II
K963694Easylyte Calcium/chloride AnalyzerMedica Corp.JFPClass II
K963655Cd Horizon Anterior Spinal SystemSofamor Danek USA,Inc.KWQClass II
K963610Aki Compacs Data Compresion Module for Diagnostic ImagesA.L.I. Technologies, Inc.LLZClass II
K963603Dermagran Hydrophilic OintmentDerma Sciences, Inc.KMFClass I
K963598Innovative Technologies Aliginate/pectin Wound DressingsInnovative Technologies, Ltd.KMFClass I
K963487Dailies (Nelfilcon a) One-Day Soft Contact LensAlcon LaboratoriesLPLClass II
K963486Revision Hip SystemSmith & Nephew Richards, Inc.JDIClass II
K963429Magnetic Resonance Diagnostic SystemGE HealthcareLNHClass II
K963029Karl Storz Slotted Whisker Arthroscopic BladeKarl Storz Endoscopy-America, Inc.HRXClass II
K963020Glovel GxKenwell International, Ltd.KGOClass I
K962984Isola Pediatric ComponentsAcromed Corp.KWPClass II
K962570Isan Sternal-Iliac Aspiration Biopsy NeedleGallini Intl., Inc.FCGClass II
K962569Biomid Bone Marrow Biopsy NeedleGallini Intl., Inc.FCGClass II
K962537Incare Hot/ice Lite MachineHollister, Inc.ILOClass II
K962481Quasar Recovery Imaging PackageTrionix Research Laboratory, Inc.KPSClass II
K962217Gen-Probe Amplified Chlamydia Trachomatis Assay KitHologic, Inc.MKZClass I
K962195Health O Meter Electric Heating Pads Models Ehp2, Ehp3Sunbeam Health DivisionIRTClass II
K962116Galileo EndoscopesGalileo Electro-Optics Corp.EOBClass II
K962061Magnetic Resonance Diagnostic SystemGE HealthcareLNHClass II
K960856Konstruct Patellar ComponentZimmer GmbHJWHClass II
K964478Osage 76Gateway Alloys, Inc.EJTClass II
K964465La Plata 34 (Pm-25)Gateway Alloys, Inc.EJTClass II
K964464Pacific 52 (Cb-39)Gateway Alloys, Inc.EJTClass II
K964312Mentor Tono-Pen 3Mentor Ophthalmics, Inc.HKYClass II
K964180Audio 'D' Sound Selector Power (Ssp)Hearing Solutions, Inc.ESDClass I
K963995Starkey Ma-3 Air Conduction Combination Hearing Aid/tinnitus MaskerStarkey Laboratories, Inc.KLWClass II
K963881Ahs Delta 22 TAuthorized Hearing Systems, Inc.ESDClass I
K963879Ahs Delta 22Authorized Hearing Systems, Inc.ESDClass I
K963876Ahs Omega PpAuthorized Hearing Systems, Inc.ESDClass I
K963874Ahs Omega AgcAuthorized Hearing Systems, Inc.ESDClass I
K963873Ahs Omega DeqAuthorized Hearing Systems, Inc.ESDClass I
K963838Starkey Tm Air Conduction Tinnitus MaskerStarkey Laboratories, Inc.KLWClass II
K963757Irrigation/suction Handle and SheathRichard Wolf Medical Instruments Corp.EOBClass II
K963745Model Wmr Bte Hearing Instrument (Model Wmr)Hearing Innovations, Inc.ESDClass I
K963704Muscle Wand, a Device for Deep Pressure Muscle MassageSummit Medical, LLCLYGClass I
K9636779Th Wave Model 200 Alternating Pressure Pad9th Wave, Inc.FNMClass II
K963648Stryker Suction RegulatorStryker Corp.GCXClass II
K9636269Th Wave Models 400 & 450 Alternating Pressure Mattress9th Wave, Inc.FNMClass II
K963510Aprema I - Alternating Pressure Air Flotation Mattress SystemMellen Air Mfg., Inc.FNMClass II
K963496Oxi TempBci Intl., Inc.DQAClass II
K963400Nellcor Symphony N-3000 Patient Monitor with Spo2 and ECG and N-3200 Display/printerMedtronic, Inc.DPSClass II
K963389Flex-Lase 600 Series Ion Laser SystemAmerican Laser MedicalGEXClass II