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510(k) K173914

VORTRAN Cuff Inflator (VCI) by Vortran Medical Technology 1, Inc. — Product Code BSK

K173914 is an FDA 510(k) premarket notification submitted by Vortran Medical Technology 1, Inc. for the device "VORTRAN Cuff Inflator (VCI)". The FDA issued a decision of Substantially Equivalent on May 25, 2018. The device falls under product code BSK (Cuff, Tracheal Tube, Inflatable), a Class II device regulated under 21 CFR 868.5750. Vortran Medical Technology 1, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 2018
Date Received
December 22, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cuff, Tracheal Tube, Inflatable
Device Class
Class II
Regulation Number
868.5750
Review Panel
AN
Submission Type

Other clearances by Vortran Medical Technology 1, Inc.

  • K202219 — VORTRAN GO2VENT with PEEP Valve (February 11, 2021)
  • K182292 — VORTRAN APM-Plus (September 18, 2019)
  • K162968 — VORTRAN GO2VENT (April 10, 2017)
  • K153733 — VORTRAN Manometer (September 16, 2016)
  • K103639 — VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (V (September 15, 2011)
  • K073261 — VAR MONITOR (May 23, 2008)
  • K041473 — VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM (July 15, 2004)
  • K003684 — PERCUSSIVENEB, MODEL PN-2001 (February 23, 2001)
  • K001430 — RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000 (July 5, 2000)
  • K982016 — PIPER IPPB MODEL 2055 (November 3, 1998)

Other clearances for product code BSK

  • K243562 — CuffGuard (August 12, 2025)
  • K242642 — CuffTrek (March 7, 2025)
  • K220854 — TrachCuff Cuff Controller (April 14, 2023)
  • K221477 — AG100s (December 29, 2022)
  • K202874 — Puritan Bennett Cuff Pressure Manager (January 9, 2021)
  • K192611 — Cuffix (August 13, 2020)
  • K191858 — Pylant Monitor (February 24, 2020)
  • K182548 — Accucuff Cuff Pressure Indicator (January 25, 2019)
  • K180991 — AG 100s (October 12, 2018)
  • K152778 — TRACOE Cuff Pressure Monitor (December 21, 2016)

FDA data resources