# K860105: Spiral-Flex

- Pathway: 510(k) (Traditional)
- Applicant: Sheridan Catheter Corp.
- Decided: Mar 4, 1986 after 50 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.
9 later devices descend from it; 3 cite it directly.
0 of 10 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
- K051993: Lma Fastrach Ett Single Use (2005), 6 descendants of its own
- K130304: Lma Family of Airways (2014), 4 descendants of its own
- K142103: Cuff Pilot, Sure Seal (2015), 3 descendants of its own
- K160694: Disposable Endotracheal tube, sterile, AccuCuff (2017), 1 descendant of its own
- K242495: LMA Fastrach ETT SU (2025), 0 descendants of its own

Source page: https://510kreport.com/device/K860105
Methodology: https://510kreport.com/methodology