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510(k) K152865

TRACOE smart Cuff Manager by Tracoe Medical GmbH — Product Code BSK

K152865 is an FDA 510(k) premarket notification submitted by Tracoe Medical GmbH for the device "TRACOE smart Cuff Manager". The FDA issued a decision of Substantially Equivalent on September 27, 2016. The device falls under product code BSK (Cuff, Tracheal Tube, Inflatable), a Class II device regulated under 21 CFR 868.5750. Tracoe Medical GmbH has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2016
Date Received
September 30, 2015
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 Tracoe Medical GmbH

  • K203362 — TRACOE vario (August 5, 2021)
  • K172720 — TRACOE silcosoft Tracheostomy Tube (April 27, 2018)
  • K152778 — TRACOE Cuff Pressure Monitor (December 21, 2016)
  • K051587 — TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, (October 25, 2005)
  • K043160 — TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO (February 18, 2005)
  • K961449 — TRACHEOSTOMY TUBES TRACOE-FLEX (September 13, 1996)
  • K781729 — TRACHEOTOMY TUBES (October 24, 1978)

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)
  • K173914 — VORTRAN Cuff Inflator (VCI) (May 25, 2018)

FDA data resources