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    FDA 510(k) K203768, Omnipod 5 ACE Pump (Pod), by Insulet Corporation

    FDA 510(k) K203768, Omnipod 5 ACE Pump (Pod), by Insulet Corporation

    $3,500.00 USD
    $3,500.00 USD
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    Device Classification Name: Alternate Controller Enabled Insulin Infusion Pump
    510(k) Number: K203768
    Device Name: Omnipod 5 ACE Pump (Pod)
    Applicant: Insulet Corporation
    Regulation Number: 880.5730
    Classification Product Code: QFG
    Date Received: 12/23/2020
    Decision Date: 01/27/2022
    Decision: Substantially Equivalent (SESE)
    Regulation Medical Specialty: Clinical Chemistry
    510k Review Panel: Clinical Chemistry

    Total number of pages: 103,460
    Fully redacted pages: 101,162
    Content pages: 2,298

    PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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