Home / 510(k) Clearances / K981080

510(k) K981080

SCOOP 1 by Transtracheal Systems — Product Code BTO

K981080 is an FDA 510(k) premarket notification submitted by Transtracheal Systems for the device "SCOOP 1". The FDA issued a decision of Substantially Equivalent on June 17, 1998. The device falls under product code BTO (Tube, Tracheostomy (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5800. Transtracheal Systems has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1998
Date Received
March 24, 1998
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 Transtracheal Systems

  • K982943 — TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000 (July 12, 1999)
  • K981078 — TRANSTRACHEAL AUGMENTED VENTILATION OXYGEN CONCENTRATOR MODEL NUMBER TTAV 1000 (July 23, 1998)
  • K962944 — TRANSTRACHEAL DEMAND OXYGEN CONTROLLER (DOC-2000) (October 23, 1996)
  • K904749 — TRANSKINETICS RADO FREQ MULTI-LEAD TELE SYST 7200 (March 1, 1991)
  • K904748 — TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 7100 (March 1, 1991)
  • K902281 — MODIFIED SCOOP TRANSTRACHEAL CATHETERS (August 10, 1990)
  • K854252 — TRANSTRACHEAL SYSTEM-SCOOP-INSERTION TRAY-CATHETER (February 3, 1986)

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