# K960450: Hebeler Safe-T-Tube

- Pathway: 510(k) (Traditional)
- Applicant: Boston Medical Products, Inc.
- Decided: Apr 19, 1996 after 80 days
- Product code: BTR (Tube, Tracheal (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Montgomery Safe-T-Tube: named in the summary without a submission number

## Indications for use
To be used as a tracheostomy tube for the following indications: 1. Provide a secondary airway; 2. Acute tracheal or laryngeal injuries; 3. A need to support intrathoracic tracheal stenosis; 4. A need to support a reconstituted trachea; 5. A need to support a reconstructed trachea; 6. Tracheal stenosis when the cervical or thoracic trachea cannot be repaired; and 7. Segmental resection and anastomosis.

Source page: https://510kreport.com/device/K960450
Methodology: https://510kreport.com/methodology