# K050853: PMP4 Spiropro

- Pathway: 510(k) (Special)
- Applicant: Card Guard Scientific Survival, Ltd.
- Decided: May 4, 2005 after 30 days
- Product code: BZH (Meter, Peak Flow, Spirometry)
- Device class: 2
- Regulation: 21 CFR 868.1860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K963725 (1997). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934795: Card Guard, Card Guard Scientific Survival, Ltd. (1995) Summary page 2.
- K042254: PMP4 Selfcheck Ecg, Card Guard Scientific Survival, Ltd. (2005) Summary page 2.

## Most influential descendants
- K072722: Meddorna Wireless PRN Spirometer 100 (2008), 0 descendants of its own
- K060703: PMP4 BP Pro Blood Pressure Monitor (2006), 0 descendants of its own

## Indications for use
The PMP4 Spiro Pro is intended for pulmonary function testing for use in hospital, clinic or home settings. It allows patients to display and transmit their pulmonary function data via a communication device to medical professionals in a remote server.

Source page: https://510kreport.com/device/K050853
Methodology: https://510kreport.com/methodology