# K031057: Per-Fit Percutaneous Dilational Tracheostomy Kit

- Pathway: 510(k) (Traditional)
- Applicant: Portex, Inc.
- Decided: Jul 18, 2003 after 106 days
- Product code: JOH (Tube Tracheostomy And Tube Cuff)
- Device class: 2
- Regulation: 21 CFR 868.5800
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K903730 (1990). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980466: Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula, Sims Portex, Inc. (1998) Summary page 1.
- K960429: Per-Fit Percutaneous Tracheostomy Kit W/Portex       Tracheostmy Tube & Disp. Inner Cannula, Smiths Industries Medical Systems, Inc. (1996) Summary page 1.
- K934465: Dic Tracheostomy Tube and Portex Blue Line, Smiths Industries Medical Systems, Inc. (1994) Summary page 2.
- K903730: D.I.C. Tracheostomy Tubes & Laryngectomy Tubes, Concord/Portex (1990) Summary page 2.
- K011210: The Percuquick Set for Percutaneous Dilation Tracheostomy, Rusch Intl. (2001)

## Most influential descendants
- K050166: Portex Emergency Cricothyroidotomy Kit (2005), 0 descendants of its own

## Recalls of this device
- Sep 18, 2007 · Not classified · Z-0100-2008: Mislabeled. The product is labeled as a size 9.0 mm tracheostomy tube, but the package contains a 7.0 mm tracheostomy tube.
- May 16, 2005 · Not classified · Z-0872-05: Guiding catheter may have thinner and weaker sidewalls than designed, and may break.
- May 16, 2005 · Not classified · Z-0867-05: Guiding catheter may have thinner and weaker sidewalls than designed, and may break.
- May 16, 2005 · Not classified · Z-0869-05: Guiding catheter may have thinner and weaker sidewalls than designed, and may break.
- May 16, 2005 · Not classified · Z-0870-05: Guiding catheter may have thinner and weaker sidewalls than designed, and may break.
- May 16, 2005 · Not classified · Z-0868-05: Guiding catheter may have thinner and weaker sidewalls than designed, and may break.
- May 16, 2005 · Not classified · Z-0871-05: Guiding catheter may have thinner and weaker sidewalls than designed, and may break.

## Indications for use
The PER-FIT Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula is indicated for use in providing percutaneous temporary tracheal access for airway management.

Source page: https://510kreport.com/device/K031057
Methodology: https://510kreport.com/methodology