# K971058: Doa-Xse, Liquid Drugs of Abuse Control Levels 2,3, and 4 (Sdoa- 202,303,404)

- Pathway: 510(k) (Traditional)
- Applicant: Medical Analysis Systems, Inc.
- Decided: Apr 8, 1997 after 15 days
- Product code: DIF (Drug Mixture Control Materials)
- Device class: 1
- Regulation: 21 CFR 862.3280
- 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
- K103656: Thermo Scientific Mas R Doa Total (2011), 0 descendants of its own

## Indications for use
The babyPAC pneumatically powered ventilator is specifically designed for use by qualified medical carcgivers, paramedics and other trained personnel for patient ventilation during respiratory distress or insufficiency in the rescue, pre-haospital and altemative site arenas.

Source page: https://510kreport.com/device/K971058
Methodology: https://510kreport.com/methodology