510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK 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
46,069 of the 176,466 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
20262,669
176,466 records, page 2671 of 3530
510(k) clearances, page 2671 of 3530
K numberDeviceApplicantProduct codeClassDecision date
K890560Spq(tm) Antibody Reagent Set II for IgaAtlantic AntibodiesCZPClass II
K884933Endostroboscope IVJEDMED Instrument CompanyEQLClass I
K884834Xomed Ionesthetizer(tm)Xomed, Inc.EGJClass II
K881765Cts-3060 Automated Semen AnalyzerMotion Analysis Corp.POVClass II
K890542Multiwell Culture Plate InsertsBD Becton Dickinson Vacutainer Systems PreanalyticKIZClass I
K890309Malis Surgical StoolValley Forge Scientific Corp.FZMClass I
K890128Facelock Filter MaskAlpha Protech, Inc.FXXClass II
K890040Modified Labeling & Packaging of Sharplan 2100Sharplan Lasers, Inc.GEXClass II
K885340Air Displacement PipetteUlster Scientific, Inc.JQWClass I
K885090Homer Mammalok Localization ShieldNorth American Instrument Corp.LROClass II
K890555Patient Mover(tm)T.B.S., Inc.ILKClass II
K890554Cp&s Disposable Instant Super Hot CompressConsolidated Products & Services, Inc.IMDClass I
K890553Cp&s Disposable Instant Cold CompressConsolidated Products & Services, Inc.IMDClass I
K890548Aquaciser SystemAquaciser, Inc.ILJClass II
K890464Zenith 40% Phosphoric Acid GelForemost Dental Mfg., Inc.EBCClass II
K890389Umbilical ScissorsKinetic Medical ProductsHDJClass I
K890388Cephalotomy ScissorsKinetic Medical ProductsKNBClass II
K890386Placenta and Ovum ForcepsKinetic Medical ProductsHCZClass II
K890384Uterine CuretteKinetic Medical ProductsHCYClass I
K890379Uterine TentaculumKinetic Medical ProductsHDCClass II
K890378Uterine Dressing ForcepsKinetic Medical ProductsHCZClass II
K890377Fixed-Size Uterine DilatorKinetic Medical ProductsHDQClass I
K890375Vaginal SpeculumKinetic Medical ProductsHDFClass I
K890357Dental Impression SyingeInnotek Dental Corp.EKJClass I
K890168Retractor, Self-RetainingDhason Brothers, Inc.LXHClass I
K890166Ronguer-OrthopedicDhason Brothers, Inc.LXHClass I
K890165Forceps-OrthopedicDhason Brothers, Inc.LXNClass I
K890164Hudson Brace W/burrsDhason Brothers, Inc.LXHClass I
K890163Austin Moore Hallow ChiselDhason Brothers, Inc.LXHClass I
K890162Extractor for Austin Moore Femoral HeadDhason Brothers, Inc.LXHClass I
K890161Thompson Type Rasp W/tommy BarDhason Brothers, Inc.LXHClass I
K890160Gouges for Femoral HeadsDhason Brothers, Inc.LXHClass I
K890158RetractorsDhason Brothers, Inc.LXHClass I
K890157ForcepsDhason Brothers, Inc.LXHClass I
K890156Impactor for Femoral HeadDhason Brothers, Inc.LXHClass I
K890085Sit-N-Bathe Sitz BathDrummond Industries, Inc.KTCClass I
K885302Gold/palladium Based Dental AlloyJelenko Co.EJTClass II
K885250Alta Tibial/upper Extremity Metaphyseal Plate SysHowmedica Corp.HRSClass II
K885233Nova DiamondMicrocopy, Div. Neo-Flo, Inc.DZPClass I
K885075Abiomed Periotemp(tm) ProbeAbiomed, Inc.EILClass I
K885010Tripton(tm) Visible Light-Cured Univ. BondingCoe Laboratories, Inc.KLEClass II
K884961Addit. Indications for Bio-Cor II Collagen CornealBausch & Lomb Pharmaceutical, Inc.MOEClass I
K884960Addit. Indication for Fyodorov Collagen CornealBausch & Lomb Pharmaceutical, Inc.MOEClass I
K884918Porcelain Etching Gel and Etching Gel BarrierParkell, Inc.KLEClass II
K884833Ultra 2000 (t.e.n.s.)Maxima Intl., Inc.GZJClass II
K884503Ultrasonic Transmission GelHerbert Stanley Co.JOTClass II
K884372Madsen Igo1500 Insertion Gain OptimizerMadsen Electronics (Canada), Ltd.ETWClass II
K884371Madsen Igo-Hat1500 Hearing Aid Dispenser SystemMadsen Electronics (Canada), Ltd.ETWClass II
K884046Audioscan(tm) Real Ear Measurement System Rm500Etymonic Design, Inc.ETWClass II
K883189Model 27080 Calcutript Electrohydraulic Lithr SysKarl Storz Endoscopy-America, Inc.FFKClass II