# K243268: TipTraQ (TTQ001)

- Pathway: 510(k) (Traditional)
- Applicant: Pranaq Pte., Ltd.
- Decided: Feb 3, 2025 after 111 days
- Product code: MNR (Ventilatory Effort Recorder)
- Device class: 2
- Regulation: 21 CFR 868.2375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K913396 (1992). 51 ancestors in all.
No later device cites it as a predicate yet.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220028: NightOwl, Ectosense NV (2022) Summary page 5.

## Indications for use
The TipTraQ is a wearable device intended for aiding in sleep apnea evaluation/diagnosis for adult patients suspected of sleep apnea in both home-based and clinical-use environments.

Source page: https://510kreport.com/device/K243268
Methodology: https://510kreport.com/methodology