# K790312: Endotracheal Tube W/Holder & Connector

- Pathway: 510(k) (Traditional)
- Applicant: Respiratory Support Products, Inc.
- Decided: Feb 21, 1979 after 8 days
- Product code: BTR (Tube, Tracheal (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5730
- Recalls of this device: 6 (6 Class I)
- 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.
1 of 1 device in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Feb 13, 2025 · Class I · Z-1289-2025: Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, underdose, or cardiopulmonary collapse.
- Jul 7, 2014 · Class I · Z-2538-2014: The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter.
- Jul 7, 2014 · Class I · Z-2537-2014: The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter.
- Jul 7, 2014 · Class I · Z-2539-2014: The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter.
- Jul 7, 2014 · Class I · Z-2536-2014: The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter.
- Apr 10, 2014 · Class I · Z-1641-2014: One lot of 3.0mm sized Connectors, Product Reorder No. 10035-05PS, Lot No. 2553426 were placed in packages labeled as size 3.5mm.

Source page: https://510kreport.com/device/K790312
Methodology: https://510kreport.com/methodology