# K971267: Shiley Extended Length, Disposable Cannula, Tracheostomy Tube: Cuffed, Distal Extension, Cuffed, Proximal Extension, Cuf

- Pathway: 510(k) (Traditional)
- Applicant: Mallinckrodt Medical
- Decided: Sep 25, 1997 after 174 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: 2 generations back to K792222 (1979). 16 ancestors in all.
No later device cites it as a predicate yet.
1 of 17 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K890194: Shiley Specialized Tracheostomy Tube, Shiley, Inc. (1989) Summary page 1.
- K962173: Shikey Tracheostomy Tubes and Accessories, Mallinckrodt Medical (1996) Summary page 1.
- K861463: Shiley Sleep Apnea Low Pressure Cuffed Trach Tube, Shiley, Inc. (1986) Summary page 1.
- K861462: Shiley Sleep Apnea Cuffless Tracheostomy Tube, Shiley, Inc. (1986) Summary page 1.
- K810106: Shiley Single Cannula Tracheostomy Tube, Shiley, Inc. (1981) Summary page 1.
- K871204: Cuffed Tracheal Tube (Multiple), Mallinckrodt Critical Care (1987) Summary page 2.
- K912240: Cpap System and Broncho-Cath W/Cpap System, Mallinckrodt Anesthesia Products (1991). Our OCR of the scanned summary read K912230, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Mallinckrodt Critical Care Broncho-Cath Right Endobronchial Tube…”.
- (no number) Smiths Industries Medical Systems (SIMS), Profile Tracheostomy Tubes with Portex Flexible Inner Tube: named in the summary without a submission number

## Indications for use
To provide tracheal access for airway management.

Source page: https://510kreport.com/device/K971267
Methodology: https://510kreport.com/methodology