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510(k) K924193

TRACHEOSTOMY CARE SET W/ HYDRO PEROX(AHC-20-54685) by American Healthcare Corp. — Product Code BTO

K924193 is an FDA 510(k) premarket notification submitted by American Healthcare Corp. for the device "TRACHEOSTOMY CARE SET W/ HYDRO PEROX(AHC-20-54685)". The FDA issued a decision of Substantially Equivalent (kit, denovo) on June 16, 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
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
June 16, 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.

  • K043543 — BLOOD GLUCOSE MONITORING SYSTEM (April 8, 2005)
  • K043512 — EASYGLUCO IGM-0002 G2 (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)
  • K923939 — IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATER (June 17, 1993)
  • K923940 — IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINE (June 17, 1993)
  • K924191 — TRACHEOSTOMY CARE SET WITH GLOVES AND EXTRA TOWEL (April 2, 1993)
  • K924195 — TRACHEOSTOMY CARE SET W/FORCEPS & GAUZE TRACH DRES (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