Identifiers
- 510(k) Number
- K053563 FDA 510(k)
- FDA Product Code
- FMF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5860 FDA 510(k)
- Regulation Number
- 880.5860 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The HumaPen Memoir is a reusable mechanical pen-injector with an electronic display, classified as a pen-type insulin delivery device (FDA Product Code: FMF). It is designed for self-administration of insulin doses, allowing precise delivery of insulin via disposable pen needles and pre-filled 3.0 mL cartridges compatible with Humalog® and Humulin® insulin formulations. The device features a memory function to record the date, time, and dosage of the last 16 injections, including priming doses, enhancing patient tracking and compliance.
The HumaPen Memoir is intended for use in home and clinical settings, requiring no sterilisation as it is reusable with disposable components. Each pen needle is single-use and detachable, while the pen body itself is cleaned and reused. The device operates independently of MRI compatibility concerns and is supplied with a dose dial adjustable in one-unit increments up to 60 units. Authorised under FDA 510(k) clearance (K053563), it adheres to traditional review standards and is distributed by Eli Lilly and Company.
Frequently asked questions
How does the memory function of the HumaPen Memoir help patients manage their insulin therapy?
The HumaPen Memoir includes a memory feature that automatically records the date, time, and dosage of the last 16 injections, including priming doses. This helps patients track their insulin usage over time, improving adherence and making it easier to share records with healthcare providers for better monitoring and personalized treatment adjustments.
Is the HumaPen Memoir compatible with all insulin types, or are there specific formulations it works with?
The device is designed to work with pre-filled 3.0 mL cartridges containing Humalog® and Humulin® insulin formulations. It is not intended for use with other insulin types or brands unless explicitly stated as compatible by the manufacturer.
How is the HumaPen Memoir cleaned and maintained for reuse, and what components are disposable?
The HumaPen Memoir itself is reusable and requires cleaning between uses, while the pen needles are single-use and detachable. The disposable components include the needles and insulin cartridges, ensuring hygiene and safety for each treatment session.
What is the maximum insulin dose that can be administered with the HumaPen Memoir, and how is the dose adjusted?
The device features a dose dial adjustable in one-unit increments, allowing for precise delivery of insulin doses up to a maximum of 60 units per injection. This makes it suitable for a wide range of patient needs, including those requiring higher doses.
Can the HumaPen Memoir be used in an MRI environment, and if not, what precautions should be taken?
The HumaPen Memoir operates independently of MRI compatibility concerns, meaning it does not contain metallic or electronic components that would interfere with MRI scans. However, patients should always confirm with their healthcare provider or MRI facility to ensure no additional precautions are required for their specific case.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Eli Lilly HumaPen Memoir Insulin Pen - Diabetes, HUMAPEN MEMOIR (K053563) — FDA 510(k) | Innolitics, PDF APR 7 006 510(k) Summary - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K053563 | Class II | Active |
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Manufacturer
- Manufacturer
- Eli Lilly And Company
Sources (1)
- FDA 510(k) K053563 24 fields · synced Sep 18, 2026