# K000045: Positube

- Pathway: 510(k) (Traditional)
- Applicant: Paraproducts, Inc.
- Decided: Mar 15, 2000 after 68 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.
4 later devices descend from it; 2 cite it directly.
1 of 5 devices 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.

## Most influential descendants
- K092611: Sonarmed Airway Monitoring System, Model 0901 (2010), 2 descendants of its own
- K143042: SonarMed AirWave, Airway Monitoring System (2016), 1 descendant of its own
- K193058: SonarMed AirWave Airway Monitoring System (2020), 0 descendants of its own
- K041917: Plasiatek Actuator (2005), 0 descendants of its own

Source page: https://510kreport.com/device/K000045
Methodology: https://510kreport.com/methodology