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510(k) K071400

SMARTSITE STOPCOCK by Cardinal Health, Alaris Products — Product Code FMG

K071400 is an FDA 510(k) premarket notification submitted by Cardinal Health, Alaris Products for the device "SMARTSITE STOPCOCK". The FDA issued a decision of Substantially Equivalent on December 14, 2007. The device falls under product code FMG (Stopcock, I.V. Set), a Class II device regulated under 21 CFR 880.5440. Cardinal Health, Alaris Products has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2007
Date Received
May 21, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stopcock, I.V. Set
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Cardinal Health, Alaris Products

  • K071108 — TEXIUM SYRINGE (May 24, 2007)
  • K061285 — SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETS (July 26, 2006)
  • K053049 — ALARIS SAFETY MALE LUER (January 12, 2006)
  • K052790 — SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD (December 23, 2005)
  • K051641 — ALARIS SYSTEM PC UNIT, MODEL 8001 (October 20, 2005)
  • K050115 — BLOOD HAND PUMP ADMINISTRATION SET (April 1, 2005)
  • K043590 — SE INFUSION SYSTEM WITH MMS (March 25, 2005)
  • K050230 — TURBO TEMP TRIO (February 16, 2005)

Other clearances for product code FMG

  • K242255 — Qitexio® 4-Way Stopcock (QIT014) (April 29, 2025)
  • K223499 — Three Way Stop Cock (July 21, 2023)
  • K223175 — lntravascular Administration Sets with Stopcock and Manifold (March 10, 2023)
  • K211204 — SafePort(TM) Manifold (or Stopcock) (September 15, 2022)
  • K210516 — Clicky Cross (May 16, 2022)
  • K190539 — TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal (October 22, 2019)
  • K190489 — Elcam Stopcocks and Manifolds (April 23, 2019)
  • K172266 — Dynarex Three-Way Stopcock (March 14, 2018)
  • K141254 — ELCAM STOPCOCKS AND MANIFOLDS (July 30, 2014)
  • K123084 — DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MA (May 23, 2013)

FDA data resources