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510(k) K820099

TRACH TAPE by Stan-Pak Ent. — Product Code BTO

K820099 is an FDA 510(k) premarket notification submitted by Stan-Pak Ent. for the device "TRACH TAPE". The FDA issued a decision of Substantially Equivalent on February 23, 1982. The device falls under product code BTO (Tube, Tracheostomy (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5800. Stan-Pak Ent. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 1982
Date Received
January 13, 1982
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 Stan-Pak Ent.

  • K823058 — DOSOMETRIC RELEASE STERILIZATION (December 9, 1982)
  • K820100 — FROSTED GLASS SLIDES (March 4, 1982)
  • K820106 — X-RAY GUAZE SPONGES (February 12, 1982)
  • K820155 — SPECIALIST CAST PADDING (February 12, 1982)
  • K820108 — TOPPER SPONGES (February 12, 1982)
  • K820107 — GUAZE SPONGES, PLAIN (February 12, 1982)
  • K820140 — WEBRIL CAST PADDING (February 12, 1982)
  • K820105 — COMBINE PAD OR ABD (February 5, 1982)
  • K820056 — TELFA STRIPS (February 5, 1982)
  • K820141 — BIAS STOCKINETTE (February 5, 1982)

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