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510(k) K211204

SafePort(TM) Manifold (or Stopcock) by Elcam Medical Acal — Product Code FMG

K211204 is an FDA 510(k) premarket notification submitted by Elcam Medical Acal for the device "SafePort(TM) Manifold (or Stopcock)". The FDA issued a decision of Substantially Equivalent on September 15, 2022. The device falls under product code FMG (Stopcock, I.V. Set), a Class II device regulated under 21 CFR 880.5440. Elcam Medical Acal has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2022
Date Received
April 22, 2021
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 Elcam Medical Acal

  • K231900 — A-TAP (previously called Arthrotap) (July 25, 2023)
  • K190489 — Elcam Stopcocks and Manifolds (April 23, 2019)
  • K141254 — ELCAM STOPCOCKS AND MANIFOLDS (July 30, 2014)
  • K123084 — DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MA (May 23, 2013)
  • K120253 — ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS) (July 16, 2012)
  • K120624 — ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT) (June 8, 2012)
  • K111467 — FLEXI-Q DV AND DVR AUTO-INJECTORS (February 9, 2012)
  • K111016 — SAFEPORT MANIFOLD (TM) (OR STOPCOCK) (June 9, 2011)
  • K100425 — HASKAL TORQUE DEVICE (June 17, 2010)
  • K082106 — ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS) (October 2, 2008)

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)
  • 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)
  • K130245 — LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENS (March 1, 2013)

FDA data resources