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510(k) K932016

TRACHEOSTOMY CARE TRAY by Clinipad Corp. — Product Code JOH

K932016 is an FDA 510(k) premarket notification submitted by Clinipad Corp. for the device "TRACHEOSTOMY CARE TRAY". The FDA issued a decision of Substantially Equivalent on November 3, 1993. The device falls under product code JOH (Tube Tracheostomy And Tube Cuff), a Class II device regulated under 21 CFR 868.5800. Clinipad Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1993
Date Received
April 23, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube Tracheostomy And Tube Cuff
Device Class
Class II
Regulation Number
868.5800
Review Panel
AN
Submission Type

Other clearances by Clinipad Corp.

  • K931560 — CARDIAC CATHETERIZATION TRAY (July 11, 1994)
  • K931668 — PICC INSERTION TRAY (March 7, 1994)
  • K932071 — I.V. START KIT (February 17, 1994)
  • K932010 — V.A.D. ACCESS KIT (February 3, 1994)
  • K932036 — LACERATION TRAY (December 13, 1993)
  • K862562 — PUNCH BIOPSY KIT (October 7, 1986)
  • K862563 — TRACHEOSTOMY CLEANSING SOLUTION (July 15, 1986)
  • K833075 — WET DRESSING KIT (January 27, 1984)
  • K833432 — CATHETER INSERTION KIT (December 28, 1983)
  • K830476 — OR PREP KIT (March 31, 1983)

Other clearances for product code JOH

  • K251313 — Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with (December 29, 2025)
  • K210833 — Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Trach (November 26, 2021)
  • K203362 — TRACOE vario (August 5, 2021)
  • K193077 — Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff (June 1, 2020)
  • K193133 — Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Mult (December 12, 2019)
  • K182861 — Shiley Neonatal/Pediatric Tracheostomy Tube (March 22, 2019)
  • K173912 — BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Perc (May 8, 2018)
  • K180034 — Weinmann Tracheostomy Exchange Set (May 7, 2018)
  • K172720 — TRACOE silcosoft Tracheostomy Tube (April 27, 2018)
  • K170720 — Portex Blue Line Ultra Paediatric Tracheosomy Tube (December 7, 2017)

FDA data resources