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510(k) K051587

TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470 by Tracoe Medical GmbH — Product Code BTO

K051587 is an FDA 510(k) premarket notification submitted by Tracoe Medical GmbH for the device "TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470". The FDA issued a decision of Substantially Equivalent on October 25, 2005. The device falls under product code BTO (Tube, Tracheostomy (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5800. Tracoe Medical GmbH has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2005
Date Received
June 15, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheostomy (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5800
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)
  • K152865 — TRACOE smart Cuff Manager (September 27, 2016)
  • 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 BTO

  • K242921 — 5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes (June 10, 2025)
  • K233713 — Pilling Tracheostomy Tubes (March 22, 2024)
  • K192511 — Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy (July 22, 2020)
  • K173384 — BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestr (April 10, 2018)
  • K120079 — PRIMED TRACHEOSTOMY TUBES (MULTIPLE) (May 24, 2012)
  • K101721 — WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA (March 24, 2011)
  • K100950 — VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE (July 13, 2010)
  • K100480 — ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH (June 11, 2010)
  • K100283 — VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PRE (April 23, 2010)
  • K083031 — PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT (August 18, 2009)

FDA data resources