VAKU-8 Blood Collection Needles
FDA 510(k) K090426 · Myco Medical Supplies, Inc.
510(k) numberK090426
Submission
- Device name
- VAKU-8 Blood Collection Needles
- Applicant
- Myco Medical Supplies, Inc.
Cary, NC, US - Received
- February 19, 2009
- Decision date
- June 12, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMI – Needle, Hypodermic, Single Lumen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5570
- Specialty
- General Hospital
Other 510(k)s with product code FMI
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| K261719 | Promisemed X-Safety Pen NeedleFMI · Special | Promisemed Hangzhou Meditech Co., Ltd. | 08/25/2026SE |
| K262427 | Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety…FMI · Special | Hh Global Technology, Inc. | 08/10/2026SE |
| K260933 | Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R…FMI · Traditional | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 08/07/2026SE |
| K261829 | Profoject Dual-Safety Pen NeedlesFMI · Traditional | CMT Health PTE., Ltd. | 07/29/2026SE |
| K260739 | Profoject Pen Needles (Model A; Model B)FMI · Traditional | CMT Health PTE., Ltd. | 07/15/2026SE |
| K260855 | Profoject Safety Pen NeedlesFMI · Traditional | CMT Health PTE., Ltd. | 06/10/2026SE |
| K254273 | Verisafe Safety Sterile Needles (SSN)FMI · Special | Promisemed Hangzhou Meditech Co., Ltd. | 04/16/2026SE |
| K252908 | Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle…FMI · Special | Sandstone Medical (Suzhou), Inc. | 03/25/2026SE |
| K253047 | PressoneFMI · Traditional | Nipro Medical Corporation | 03/24/2026SE |
| K253622 | Safety Pen NeedleFMI · Traditional | Ningbo Medsun Medical Co., Ltd. | 03/18/2026SE |
More from Ningbo Medsun Medical Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K203668 | RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles…BSP · Traditional | 09/29/2021SE |
| K173279 | RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube HolderFMI · Traditional | 05/14/2018SE |
| K042504 | Cathy Sterile Disposable I.V. Cannula with CatheterFOZ · Traditional | 01/19/2006SE |
| K000592 | Unolok Plus Infusion Set and VAKU-8 Plus Blood Collection SetFPA · Traditional | 04/12/2001SE |
| K990519 | Phoenix Epidural & Spinal NeedlesBSP · Traditional | 06/02/2000SE |
| K982646 | Ailee Sutures and Ailee NeedlesGAL · Traditional | 06/02/1999SE |
| K990388 | Tutoplus IV Administration SetFPA · Traditional | 03/29/1999SE |
| K982098 | Tutodrop 1 and Tutodrop 2FPA · Traditional | 03/01/1999SE |
| K963364 | Glass Van Glass SyringesFMF · Traditional | 05/01/1998SE |
| K953252 | Disposable Scalp Vein Infusion SetFOZ · Traditional | 11/26/1996SE |
Questions and answers
When was VAKU-8 Blood Collection Needles cleared by the FDA?
VAKU-8 Blood Collection Needles (K090426) received a 510(k) decision of Substantially Equivalent on June 12, 2009, 113 days after the submission was received.
What is the product code of K090426?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.