# K010460: Lifelines Trackit

- Pathway: 510(k) (Traditional)
- Applicant: Lifelines, Ltd.
- Decided: May 14, 2001 after 87 days
- Product code: OLV (Standard Polysomnograph With Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K093728: BE Micro, Trea (2010), 4 descendants of its own
- K133355: Cadwell Flex Eeg/PSG (2014), 3 descendants of its own
- K180269: Cadwell Apollo System (2018), 2 descendants of its own
- K201819: Cadwell Apollo System (2020), 1 descendant of its own
- K221959: Q21 (2023), 0 descendants of its own

Source page: https://510kreport.com/device/K010460
Methodology: https://510kreport.com/methodology