# K112915: Spirtius Cuff Inflation Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Spiritus Technologies, LLC
- Decided: May 25, 2012 after 235 days
- Product code: BSK (Cuff, Tracheal Tube, Inflatable)
- Device class: 2
- Regulation: 21 CFR 868.5750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K791045 (1979). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912723: Posey Cufflator, Posey Co. (1991) Summary page 1.
- K885216: Attachable Lanz (Tentative), Mallinckroot, Inc. (1989) Summary page 1.
- K791045: Model GV-10 Lanz Pressure-Valve, Extracorporeal Medical Specialities, Inc. (1979) Summary page 1.
- K871204: Cuffed Tracheal Tube (Multiple), Mallinckrodt Critical Care (1987) Summary page 3.

## Indications for use
The SCIS will be used to inflate to 25±2 cmH2O the cuff of a high-volume, low-pressure endotracheal tube that has been intubated by a trained medical professional.

Source page: https://510kreport.com/device/K112915
Methodology: https://510kreport.com/methodology