# K960429: Per-Fit Percutaneous Tracheostomy Kit W/Portex       Tracheostmy Tube & Disp. Inner Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Industries Medical Systems, Inc.
- Decided: May 2, 1996 after 92 days
- Product code: JOH (Tube Tracheostomy And Tube Cuff)
- Device class: 2
- Regulation: 21 CFR 868.5800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K903730 (1990). 3 ancestors in all.
32 later devices descend from it; 2 cite it directly.
4 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K936133: Percutaneous Tracheostomy Kit, Smiths Industries Medical Systems, Inc. (1994) Summary page 1.
- K903730: D.I.C. Tracheostomy Tubes & Laryngectomy Tubes, Concord/Portex (1990) Summary page 1.
- K912124: Tracheostomy Tube and Cuff, Concord/Portex (1991) Summary page 1.
- (no number) Cook Critical Care Ciaglia Percutaneous Tracheostomy Introducer Set: named in the summary without a submission number

## Most influential descendants
- K980466: Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula (1998), 31 descendants of its own
- K030570: Blue Line Ultra Suctionaid Tracheostomy Tube (2003), 21 descendants of its own
- K032112: P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed) (2004), 12 descendants of its own
- K030381: Portex Blue Line Ultra Tracheostomy Tube (Cuffed) with Reusable Inner Cannula (2003), 8 descendants of its own
- K051993: Lma Fastrach Ett Single Use (2005), 6 descendants of its own

## Indications for use
The SIMS PER-FIT™ Percutaneous Tracheostomy Kit with Portex® Tracheostomy Tube and Disposable Inner Cannula is indicated for use in providing percutaneous temporary tracheal access for airway management. The Disposable Inner Cannulae are indicated for use in maintaining airway patency of the outer cannula in the presence of thick tenacious secretions or when it is desirable to minimize the cleaning materials and the nursing tirae required. The Disposable Inner Cannulae provide a means to protect against the risk of airway obstruction, contamination, and infection. The Per-Fit™ Percutaneous Tracheostomy Tube is intended for use as a replacement tube for the percutaneous tracheostomy tube that is supplied in the Per-Fit™ Percutaneous Tracheostomy Kit. It is intended to be used for replacement during the initial procedure or as a change-out tube following the procedure.

Source page: https://510kreport.com/device/K960429
Methodology: https://510kreport.com/methodology