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510(k) K243562

CuffGuard by Idmed — Product Code BSK

K243562 is an FDA 510(k) premarket notification submitted by Idmed for the device "CuffGuard". The FDA issued a decision of Substantially Equivalent on August 12, 2025. The device falls under product code BSK (Cuff, Tracheal Tube, Inflatable), a Class II device regulated under 21 CFR 868.5750. Idmed has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2025
Date Received
November 18, 2024
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 Idmed

  • K243339 — WiTOF (June 23, 2025)
  • K172690 — ToFscan (May 31, 2018)

Other clearances for product code BSK

  • 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)
  • K173914 — VORTRAN Cuff Inflator (VCI) (May 25, 2018)
  • K152778 — TRACOE Cuff Pressure Monitor (December 21, 2016)

FDA data resources