Pen-Inject 2.25
FDA 510(k) K954729 · Scandinavian Health , Ltd.
510(k) numberK954729
Submission
- Device name
- Pen-Inject 2.25
- Applicant
- Scandinavian Health , Ltd.
Washington, DC, US - Received
- October 13, 1995
- Decision date
- January 29, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KZH – Introducer, Syringe Needle
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6920
- Specialty
- General Hospital
Other 510(k)s with product code KZH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243232 | GripMateKZH · Traditional | Synthon Hispania S.L. | 12/02/2024SE |
| K213429 | AccuSert Needle InserterKZH · Traditional | Emed Technologies Corporation | 10/20/2022SE |
| K163400 | Orbit InserterKZH · Traditional | Ypsomed AG | 07/26/2017SE |
| K160860 | MiniMed Quick-serterKZH · Traditional | Medtronic Minimed | 09/22/2016SE |
| K141384 | Whisperject AutoinjectorKZH · Abbreviated | Scandinavian Health Limited | 09/12/2014SE |
| K124026 | Lobster Auto-InjectorKZH · Traditional | Scandinavian Health Limited | 09/13/2013SE |
| K122837 | Autoject 2 for Glassy SyringeKZH · Special | Owen Mumford, Ltd. | 10/15/2012SE |
| K111467 | Flexi-Q DV and DVR Auto-InjectorsKZH · Traditional | Elcam Medical Acal | 02/09/2012SE |
| K082587 | Auto-Safety INJECTOR-2 (ASI-2)KZH · Traditional | Medical House Products Limited | 10/02/2008SE |
| K073476 | Compact Auto-Safety Injector (Casi)KZH · Traditional | Medical House (Asi) Limited | 03/07/2008SE |
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Questions and answers
When was Pen-Inject 2.25 cleared by the FDA?
Pen-Inject 2.25 (K954729) received a 510(k) decision of Substantially Equivalent on January 29, 1996, 108 days after the submission was received.
What is the product code of K954729?
The FDA product code is KZH – Introducer, Syringe Needle, a Class II (moderate risk) device regulated under 21 CFR 880.6920.