# K131786: Airstrip Remote Patient Monitoring Philips Adapter

- Pathway: 510(k) (Traditional)
- Applicant: Airstrip Technologies, LP
- Decided: Jul 3, 2013 after 15 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- 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 RPM is software capable of displaying physiologic and other patient information. This information is generated by other medical devices and patient information system, and not by AirStrip RPM. AirStrip RPM captures this information from these other systems and displays it for clinicians. AirStrip RPM is intended to be used by clinicians for the following purposes: - By using a cellular telephone or other device on which AirStrip RPM is installed, to review physiologic data of a patient when the clinician is not at the hospital *To view the near real-time waveforms remotely *To remotely review other standard or critical near real-time patient data from the monitored system *To provide a request for remote consultation regarding a patient's waveform or other data The AirStrip RPM software can display the following the physiologic data captured by other medical devices: * ECG Waveform *Heart Rate Monitored * Respiratory Rate *Oxygen Saturation *Intracranial Pressure * Central Venous Pressure * Pulmonary Capillary Wedge Pressure * Cardiac Index * Cardiac Output * Cerebral Perfusion Pressure * Urine Output "Urine/Stool Mix Output * Systolic Blood Pressure Invasive * Mean Arterial Pressure Invasive * Diastolic Blood Pressure Invasive * Systolic Blood Pressure Cuff * Mean Arterial Pressure Cuff * Diastolic Blood Pressure Cuff * Vasoactive Infusions "Antiarrhythmics *Sedation *Paralytics "Laboratory Data including - Blood Gas - Chemistry - Hematology - Coagulation *Allergies * Medications Airstrip RPM software is intended for installation on cellular telephones and other wireless devices, and is not intended for use anywhere cellular telephones or wireless devices are prohibited. AirStrip RPM is intended for use by clinicians when they cannot be at the hospital. AirStrip RPM is intended for use by clinicians as a diagnostic aid, and not as a replacement for direct viewing of any of the monitoring devices from which it obtains its data.

Source page: https://510kreport.com/device/K131786
Methodology: https://510kreport.com/methodology