510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK 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
45,969 of the 176,366 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
20262,569
176,366 records, page 3288 of 3528
510(k) clearances, page 3288 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K8107487.5 Mhz Wp TransducerGeneral Electric Co.ITXClass II
K811614Nerve Stimulator Model Aa 1050Anesthesia Assoc., Inc.BXNClass II
K811560Automated Physiologic Profile MonitorLife Sciences Manufacturing, Inc.DXGClass II
K811558Tsh-P.e.g.Nuclear Diagnostics, Inc.JLWClass II
K811553Reagent Set TriglyceridesBoehringer Mannheim Corp.CHIClass I
K811551Timeter Produced Ohio Oxygen AdaptorTimeter Instrument Corp.BYXClass I
K811550Timeter Produced Chemetron (Ncg) AirTimeter Instrument Corp.BYXClass I
K811549Timeter Produced Schrader Oxygen AdaptorTimeter Instrument Corp.BYXClass I
K811547Matelas Coquille Lattrede TassignyFirn-FranceFPPClass I
K811542Mgn Suction CatheterMgn Medical Manufacturing, Inc.BSYClass I
K811541Mgn Connecting TubeMgn Medical Manufacturing, Inc.BYYClass II
K811537Model Sp 5507 5-Lumen Thermodilution CatGould, Inc.KRBClass II
K811536Direct Testosterone RiaImmuchem Corp.CDZClass I
K811525Flexigram Auto Loader SystemElectro-Nucleonics Laboratories, Inc.JJGClass I
K811513Wilkins-Chalgren Anaerobe AgarOxoid U.S.A., Inc.JSOClass II
K811505Monoject Sterile M503 3Cc SyringesSherwood Medical Co.FMFClass II
K811500Colbalt Alloy Orthopaedic WireOsteonics Corp.JDRClass II
K811479Chodolate Agar, EnrichedBiomedia, Inc.JTYClass II
K811478Emb Agar, LevineBiomedia, Inc.JSIClass I
K811477Macconkey AgarBiomedia, Inc.JSIClass I
K811476Thayer Martin AgarBiomedia, Inc.JTYClass II
K811475Tryptic Soy Agar W/5% & 10% Sheep BloodBiomedia, Inc.JSGClass I
K811474Tryptic Soy Agar W/5% Sheep Blood & EmbBiomedia, Inc.JSIClass I
K811473Mueller Hinton Agar W/5% Sheep BloodBiomedia, Inc.JTZClass II
K811472Mueller Hinton Agar, Poured into a PlateBiomedia, Inc.JTZClass II
K811471Mueller Hinton AgarBiomedia, Inc.JTZClass II
K811442Kwik-Lac Beta-Lactamase KitsWindsor Laboratories, Inc.
K811422Strep-Id PlateCarr-Scarborough Microbiologicals, Inc.JSIClass I
K811400HemaquikAccra Laboratories, Inc.IAFClass I
K811352Polaroid Tpx Radiographic FilmPolaroid Corp.IWZClass I
K811268Bottle-to-BottleMedi-Plast Intl., Inc.KPEClass II
K811266Quinton Catheter Finger GripQuinton, Inc.FKOClass II
K811234i.v. Bottle (Ridgid)Medi-Plast Intl., Inc.KPEClass II
K811173Struva & MediWecoFQMClass I
K810893Hewlett-Packard VentilatorHewlett-Packard Co.CBKClass II
K811233i.v. Plastic BagMedi-Plast Intl., Inc.KPEClass II
K811703Cardiff Aldasorber SystemWilliam Harvey Life Products Corp.
K811527Cc-103Anthro-Metrics Corp.DSIClass II
K811509Auto-Tympanigraph (Ta-5A)Teledyne Avionics Div. of TeledyneETYClass II
K811496Gottschalk Nasostat Slim Line, Adult/sm.Narco ScientificEMXClass I
K811494Lumbo-Sacral Flexion OrthosisSurgical Appliance Industries, Inc.IPYClass I
K811486Wheelchair RampsFred Sammons, Inc.KNOClass I
K811485Walker/crutch BagFred Sammons, Inc.ITJClass I
K811484Seating StoolsFred Sammons, Inc.INNClass I
K811483Stim StandFred Sammons, Inc.ILPClass I
K811455Anis Guiding CannulaAmerican V. MuellerHMXClass I
K811443Enhance Dental RestorativeJohnson & Johnson Professionals, Inc.EBFClass II
K811433Scrippsera Complement Control SeraScripps-Miles, Inc.DHLClass I
K811428Northwestern Voice Restoration KitUniversal Prosthetics, Inc.KACClass I
K811420Minerals Modified Med. Base & Sod. Glut.Oxoid U.S.A., Inc.JSIClass I