Home / 510(k) Clearances / K090426

510(k) K090426

VAKU-8 BLOOD COLLECTION NEEDLES by Myco Medical Supplies, Inc. — Product Code FMI

K090426 is an FDA 510(k) premarket notification submitted by Myco Medical Supplies, Inc. for the device "VAKU-8 BLOOD COLLECTION NEEDLES". The FDA issued a decision of Substantially Equivalent on June 12, 2009. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Myco Medical Supplies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2009
Date Received
February 19, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

Other clearances by Myco Medical Supplies, Inc.

  • K203668 — RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal N (September 29, 2021)
  • K173279 — RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder (May 14, 2018)
  • K042504 — CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER (January 19, 2006)
  • K000592 — UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET (April 12, 2001)
  • K990519 — PHOENIX EPIDURAL & SPINAL NEEDLES (June 2, 2000)
  • K982646 — AILEE SUTURES AND AILEE NEEDLES (June 2, 1999)
  • K990388 — TUTOPLUS IV ADMINISTRATION SET (March 29, 1999)
  • K982098 — TUTODROP 1 AND TUTODROP 2 (March 1, 1999)
  • K963364 — GLASS VAN GLASS SYRINGES (May 1, 1998)
  • K953252 — DISPOSABLE SCALP VEIN INFUSION SET (November 26, 1996)

Other clearances for product code FMI

  • K260739 — Profoject™ Pen Needles (Model A; Model B) (July 15, 2026)
  • K260855 — Profoject™ Safety Pen Needles (June 10, 2026)
  • K254273 — Verisafe Safety Sterile Needles (SSN) (April 16, 2026)
  • K252908 — Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen (March 25, 2026)
  • K253047 — PRESSONE™ (March 24, 2026)
  • K253622 — Safety Pen Needle (March 18, 2026)
  • K252886 — Pen Needle (January 6, 2026)
  • K250700 — Pen Injector Needle 32.5 (November 21, 2025)
  • K252631 — Profoject™ Disposable Needle (October 16, 2025)
  • K250724 — Intraosseous Infusion Needles (July 30, 2025)

FDA data resources