Humapen Memoir
FDA 510(k) K053563 · Eli Lilly and Company
510(k) numberK053563
Submission
- Device name
- Humapen Memoir
- Applicant
- Eli Lilly and Company
Indianapolis, IN, US - Received
- December 21, 2005
- Decision date
- April 7, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMF – Syringe, Piston
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5860
- Specialty
- General Hospital
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| K262581 | GraftGun Universal Graft Delivery System (GDS®)FMF · Special | SurGenTec, LLC | 08/26/2026SE |
| K252184 | SOL-M Luer Lock Syringe with Exchangeable Needle TrayFMF · Traditional | Sol-Millennium Medical, Inc. | 08/25/2026SE |
| K253747 | Disposable Pen Injector (KXYC-03C02, KXYC-03A03)FMF · Traditional | Jiangsu Enjosim Medical Technology Co., Ltd. | 08/14/2026SE |
| K260208 | Ultra-Fine SAFETY Insulin SyringeFMF · Traditional | embecta Medical II, LLC | 07/13/2026SE |
| K253110 | Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeFMF · Traditional | Sol-Millennium Medical, Inc. | 06/18/2026SE |
| K260514 | Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead…FMF · Traditional | CMT Health PTE., Ltd. | 06/12/2026SE |
| K253112 | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec…FMF · Special | Hlb Lifescience Co., Ltd. | 05/21/2026SE |
| K252279 | Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)FMF · Traditional | Chirana T.Injecta,A.S. | 04/17/2026SE |
| K253068 | Profoject Insulin Syringes; Profoject Safelock Disposable Insulin SyringeFMF · Traditional | CMT Health PTE., Ltd. | 02/23/2026SE |
| K253769 | Instylla Delivery KitFMF · Special | Instylla, Inc. | 12/22/2025SE |
More from Instylla, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K212217 | Tempo Smart ButtonQOG · Traditional | 09/16/2022SE |
| K160949 | Go Dose SystemNDC · Traditional | 12/22/2016SE |
| K160668 | HumaPen SavvioFMF · Traditional | 06/03/2016SE |
| K151686 | HumanPen Ergo IIFMF · Traditional | 12/30/2015SE |
| K142518 | HumaPen LuxuraFMF · Traditional | 06/05/2015SE |
| K100988 | Humapen Luxura HDFMF · Traditional | 08/17/2010SE |
| K063151 | Humapen Luxura HDNSC · Traditional | 01/09/2007SE |
| K982842 | Humapen and Humapen ErgoFMF · Traditional | 09/25/1998SE |
Questions and answers
When was Humapen Memoir cleared by the FDA?
Humapen Memoir (K053563) received a 510(k) decision of Substantially Equivalent on April 7, 2006, 107 days after the submission was received.
What is the product code of K053563?
The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.