# K850964: Double-Swivel Connector

- Pathway: 510(k) (Traditional)
- Applicant: Sheridan Catheter Corp.
- Decided: May 14, 1985 after 67 days
- Product code: BZA (Connector, Airway (Extension))
- Device class: 1
- Regulation: 21 CFR 868.5810
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have 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.

## Most influential descendants
- K083702: Trach-Assist (2009), 0 descendants of its own

## Recalls of this device
- Jul 31, 2009 · Not classified · Z-1941-2009: The tether attaching to the double swivel cap may partially or completely break at the attachment points, resulting in the potential of the accidental aspiration of the tether into the patient's lungs
- Jul 31, 2009 · Not classified · Z-1942-2009: The tether attaching to the double swivel cap may partially or completely break at the attachment points, resulting in the potential of the accidental aspiration of the tether into the patient's lungs
- Jul 31, 2009 · Not classified · Z-1940-2009: The tether attaching to the double swivel cap may partially or completely break at the attachment points, resulting in the potential of the accidental aspiration of the tether into the patient's lungs
- Jul 31, 2009 · Not classified · Z-1944-2009: The tether attaching to the double swivel cap may partially or completely break at the attachment points, resulting in the potential of the accidental aspiration of the tether into the patient's lungs
- Jul 31, 2009 · Not classified · Z-1943-2009: The tether attaching to the double swivel cap may partially or completely break at the attachment points, resulting in the potential of the accidental aspiration of the tether into the patient's lungs

Source page: https://510kreport.com/device/K850964
Methodology: https://510kreport.com/methodology