# K042082: Airstrip OB

- Pathway: 510(k) (Traditional)
- Applicant: Mp4 Solutions, LP
- Decided: Jan 21, 2005 after 171 days
- Product code: HGM (System, Monitoring, Perinatal)
- Device class: 2
- Regulation: 21 CFR 884.2740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
AirStrip OB® is intended to be used by Obstetricians for the following purposes: * To more rapidly and thoroughly respond to a nurse call regarding fetal heart tracings or maternal contraction patterns by viewing the real time waveforms remotely using a mobile device such as a PDA or Smart Phone * To proactively review a fetal heart or maternal contraction tracing of a patient in Labor and Delivery for whom they are responsible but are unable to be present in the hospital at that time. * To review the current Labor and Delivery patient census list. * Provide a request for remote consultation regarding a fetal heart tracing. * To remotely review other standard or critical real-time numeric data from Labor and Delivery.

Source page: https://510kreport.com/device/K042082
Methodology: https://510kreport.com/methodology