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510(k) K924191

TRACHEOSTOMY CARE SET WITH GLOVES AND EXTRA TOWEL by American Healthcare Corp. — Product Code BTO

K924191 is an FDA 510(k) premarket notification submitted by American Healthcare Corp. for the device "TRACHEOSTOMY CARE SET WITH GLOVES AND EXTRA TOWEL". The FDA issued a decision of Substantially Equivalent (kit) on April 2, 1993. The device falls under product code BTO (Tube, Tracheostomy (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5800. American Healthcare Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
April 2, 1993
Date Received
August 20, 1992
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 American Healthcare Corp.

  • K043512 — EASYGLUCO IGM-0002 G2 (April 8, 2005)
  • K043543 — BLOOD GLUCOSE MONITORING SYSTEM (April 8, 2005)
  • K031501 — EASYGLUCO, MODEL IGM0002 (October 16, 2003)
  • K924192 — I.V. START KIT (AHC-50-54954 (August 27, 1993)
  • K923941 — IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINE (June 17, 1993)
  • K923938 — IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATER (June 17, 1993)
  • K923940 — IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINE (June 17, 1993)
  • K923939 — IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATER (June 17, 1993)
  • K924193 — TRACHEOSTOMY CARE SET W/ HYDRO PEROX(AHC-20-54685) (June 16, 1993)
  • K924194 — TRACHEOSTOMY CARE SET W/EXTRA TOWEL(AHC-20-54686) (January 6, 1993)

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