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510(k) K220854

TrachCuff Cuff Controller by Aw Technologies Aps — Product Code BSK

K220854 is an FDA 510(k) premarket notification submitted by Aw Technologies Aps for the device "TrachCuff Cuff Controller". The FDA issued a decision of Substantially Equivalent on April 14, 2023. The device falls under product code BSK (Cuff, Tracheal Tube, Inflatable), a Class II device regulated under 21 CFR 868.5750.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2023
Date Received
March 23, 2022
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 for product code BSK

  • K243562 — CuffGuard (August 12, 2025)
  • K242642 — CuffTrek (March 7, 2025)
  • 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)
  • K173914 — VORTRAN Cuff Inflator (VCI) (May 25, 2018)
  • K152778 — TRACOE Cuff Pressure Monitor (December 21, 2016)

FDA data resources