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510(k) K112512

VANISHPOINT BLOOD COLLECTION SET by Retractable Technologies, Inc. — Product Code FPA

K112512 is an FDA 510(k) premarket notification submitted by Retractable Technologies, Inc. for the device "VANISHPOINT BLOOD COLLECTION SET". The FDA issued a decision of Substantially Equivalent on October 20, 2011. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Retractable Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2011
Date Received
August 30, 2011
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 Retractable Technologies, Inc.

  • K202325 — EasyPoint Blood Collection Plus (April 9, 2021)
  • K133635 — EASYPOINT NEEDLE (June 17, 2014)
  • K122355 — VANISHPOINT BLOOD COLLECTION SET (August 23, 2013)
  • K101708 — PATIENT SAFE LUER CAP (February 24, 2011)
  • K081420 — VANISHPOINT I.V. CATHETER (November 7, 2008)
  • K072654 — PATIENT SAFE SYRINGE (December 14, 2007)
  • K051355 — VANISHPOINT I.V. CATHETER (September 23, 2005)
  • K980069 — VANISHPOINT SYRINGE (February 12, 1998)
  • K973301 — ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE/VANISHPOINT SYRINGE (November 7, 1997)
  • K971763 — BLOOD COLLECTION TUBE HOLDER VANISHPOINT TUBE HOLDER/SMALL TUBE ADAPTER (August 26, 1997)

Other clearances for product code FPA

  • K254123 — Ecomed Disposable Administration Sets (September 11, 2026)
  • 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)

FDA data resources