# K033402: Portable Sleep Data Recorder (PSDR)

- Pathway: 510(k) (Traditional)
- Applicant: Pro-Tech Services, Inc.
- Decided: Jun 30, 2004 after 250 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K080375: RMX Physiological Data Recorder (2008), 0 descendants of its own

## Indications for use
The PSDR system is a physiological recorder intended to display and to record for later play back of oxygen saturation, pulse rate, airflow, thoracic and abdominal respiratory effort, periodic limb movement, body position data, and a 0-1 volt DC signal (such as CPAP pressure) on the auxiliary input. The PSDR is designed to be used in a supervised (hospital/institutional) or unsupervised (home) environment.

Source page: https://510kreport.com/device/K033402
Methodology: https://510kreport.com/methodology