# K043162: PMP4 Oxy Pro

- Pathway: 510(k) (Traditional)
- Applicant: Card Guard Scientific Survival, Ltd.
- Decided: Dec 29, 2004 after 43 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K910772 (1991). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041156: Avant Digital Pulse Oximetry System, Models 4000, 4001, Nonin Medical, Inc. (2004) Summary page 4.

## Indications for use
The PMP4 Oxy Pro digital pulse oximeter system is intended for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients in different settings: a) At hospitals, homes and alternate-sites as well as for EMS environment and for transport use. b) At remote locations, where patients can obtain, display and transmit their pulse oximeter vital signs data to a medical expert via a communication device, such as a PDA or a remote server.

Source page: https://510kreport.com/device/K043162
Methodology: https://510kreport.com/methodology