# K980466: Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Sims Portex, Inc.
- Decided: Feb 24, 1998 after 18 days
- Product code: JOH (Tube Tracheostomy And Tube Cuff)
- Device class: 2
- Regulation: 21 CFR 868.5800
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K903730 (1990). 4 ancestors in all.
31 later devices descend from it; 4 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)
- K960429: Per-Fit Percutaneous Tracheostomy Kit W/Portex       Tracheostmy Tube & Disp. Inner Cannula, Smiths Industries Medical Systems, Inc. (1996) Summary page 1.
- (no number) Ciaglia Percutaneous Tracheostomy Introducer Set: named in the summary without a submission number

## Most influential descendants
- 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
- K073383: Well Lead Reinforced Endotracheal Tube (2008), 5 descendants of its own

## Recalls of this device
- Dec 12, 2003 · Not classified · Z-0569-04: Lid tray incorrectly labeled as Tube I.D. 7.0 mm instead of correct size 8.0 mm

## 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/K980466
Methodology: https://510kreport.com/methodology