# K041348: Portex Ultraperc Percutaneous Dilation Tracheostomy Kit_with Serial Dilators or Single Stage Dilator, Blue Line Ultra

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical
- Decided: Jul 13, 2004 after 54 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: 5 generations back to K920547 (1992). 44 ancestors in all.
5 later devices descend from it; 3 cite it directly.
2 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022212: Portex Percutaneous Dilatational Tracheostomy Kits, Mentor Medical Limited (2003) Summary page 1.
- K040014: Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator and Soft Introducers for Sizes 7, 8 and 9MM Tubes Only, Portex, Ltd. (2004) Summary page 1.
- K030381: Portex Blue Line Ultra Tracheostomy Tube (Cuffed) with Reusable Inner Cannula, Portex, Ltd. (2003) Summary page 1.
- K980466: Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula, Sims Portex, Inc. (1998) Summary page 1.
- K011210: The Percuquick Set for Percutaneous Dilation Tracheostomy, Rusch Intl. (2001)
- K880247: Modified Shiley Low Pressure Cuffed Tracheo. Tubes, Shiley, Inc. (1988) Summary page 1.

## Most influential descendants
- K133597: Ciaglia Percutaneous Tracheostomy Introducer Set/Tray, Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set/Tray (2014), 2 descendants of its own
- K180034: Weinmann Tracheostomy Exchange Set (2018), 1 descendant of its own
- K193133: Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set (2019), 0 descendants of its own
- K173912: BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube (2018), 0 descendants of its own
- K083031: Portex Uniperc Percutaneous Dilation Tracheostomy Kit (2009), 0 descendants of its own

## Recalls of this device
- May 14, 2021 · Class II · Z-1993-2021: One lot number of a specific model of ULTRAperc Percutaneous Dilation Tracheostomy Kit, 9.0mm may have been incorrectly labeled as a 7.0mm ID kit.

## Indications for use
The Portex Percutaneous Dilation Tracheostomy kit with Serial Dilators or Single Stage Dilator, Blue Line Ultra Tracheostomy Tube and Introducer are indicated to create a percutaneous dilational tracheostomy using guidewire dilator/s and components of these kits that allow for tracheal access for airway management for use in adults only.

Source page: https://510kreport.com/device/K041348
Methodology: https://510kreport.com/methodology