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510(k) K000592

UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET by Myco Medical Supplies, Inc. — Product Code FPA

K000592 is an FDA 510(k) premarket notification submitted by Myco Medical Supplies, Inc. for the device "UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET". The FDA issued a decision of Substantially Equivalent on April 12, 2001. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Myco Medical Supplies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2001
Date Received
February 22, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
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)
  • K090426 — VAKU-8 BLOOD COLLECTION NEEDLES (June 12, 2009)
  • K042504 — CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER (January 19, 2006)
  • 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 FPA

  • K261530 — iiSure Infusion Set (June 3, 2026)
  • K252543 — AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, (May 4, 2026)
  • K251375 — PuraCath Firefly Needleless Connector IT (9005) (February 12, 2026)
  • K251257 — nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Fre (December 4, 2025)
  • K250325 — BD Alaris Pump Infusion Set (October 30, 2025)
  • K251814 — EZ™ IV Administration Set (August 29, 2025)
  • K251854 — SteadiSet infusion set (August 6, 2025)
  • K243841 — Sparta Infusion Set for Insulin (August 1, 2025)
  • K243392 — Infusomat® Space Volumetric Infusion Pump Administration Sets (July 24, 2025)
  • K250616 — Clave™ Neutral-Displacement Needlefree Connectors (June 5, 2025)

FDA data resources