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510(k) K971763

BLOOD COLLECTION TUBE HOLDER VANISHPOINT TUBE HOLDER/SMALL TUBE ADAPTER by Retractable Technologies, Inc. — Product Code FMI

K971763 is an FDA 510(k) premarket notification submitted by Retractable Technologies, Inc. for the device "BLOOD COLLECTION TUBE HOLDER VANISHPOINT TUBE HOLDER/SMALL TUBE ADAPTER". The FDA issued a decision of Substantially Equivalent on August 26, 1997. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Retractable Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1997
Date Received
May 13, 1997
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 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)
  • K112512 — VANISHPOINT BLOOD COLLECTION SET (October 20, 2011)
  • 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)

Other clearances for product code FMI

  • K261266 — MOWANA™ Auto Duo (September 17, 2026)
  • K261719 — Promisemed X-Safety Pen Needle (August 25, 2026)
  • K262427 — Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, (August 10, 2026)
  • K260933 — Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, N (August 7, 2026)
  • K261829 — Profoject™ Dual-Safety Pen Needles (July 29, 2026)
  • 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)

FDA data resources