# K211949: AirStrip ONE Web Client with Alarm Communication Management (ACM)

- Pathway: 510(k) (Special)
- Applicant: Airstrip Technologies, Inc.
- Decided: Dec 9, 2021 after 169 days
- Product code: MSX (System, Network And Communication, Physiological Monitors)
- 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
Longest line of descent: 1 generation back to K160862 (2016). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160862: AirStrip RPM, Airstrip Technologies, Inc. (2016) Summary page 5.

## Indications for use
AirStrip ONE Web Client with ACM is intended to allow clinicians to capture and display waveforms (such as ECG, SpO2, ART), discrete parameters, patient demographics, alarms, and other information from medical devices on a desktop device. This software is intended as a diagnostic aid to provide access for professional staff to view patient clinical data when the professional cannot observe the source system directly. AirStrip ONE Web Client with ACM does not store Protected Healthcare Information on the device accessing the data. Data available on the web viewer is in “near real time” and is displayed to show a full range of clinical data available, even when the data sources are obtained from different devices. AirStrip ONE Web Client with ACM gathers data from the medical devices that are connected to the patient. AirStrip ONE Web Client with ACM is not directly connected to the individual, but to a networked medical device receiving data, and connects that data to individuals by medical record number or defined patient ID. AirStrip ONE Web Client with ACM is intended to be used by clinicians for the following purposes: » To visualize physiological data using a web viewer to assess clinical status of a patient when the source system cannot be observed directly by the clinician. * To view the near real-time and historic waveforms. » To view other near real-time patient data from a monitored system. * To provide a request for remote consultation regarding a patient’s waveform or other data. * To send electronic images of the cardiac rhythm to the medical record. » To allow clinicians to manage secondary alarm transmission by suppressing non-critical alarms. AirStrip ONE Web Client with ACM is appropriate for use in pediatric (0-21 years), adult and geriatric populations, as the networked medical devices AirStrip collects data from are already cleared for these populations. AirStrip ONE Web Client with ACM software can display the following physiologic parameters and waveforms captured by other cleared medical devices: * ECG Waveform *» Heart Rate * Respiratory Rate * Oxygen Saturation * Intracranial Pressure » Central Venous Pressure * Pulmonary Capillary Wedge Pressure » Pulmonary Artery Pressure * Cardiac Index * Cardiac Output » Cerebral Perfusion Pressure » Temperature » Temperature Source o Bispectral index (BIS) o Umbilical Artery o Body Weight » 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 * Ventilators * Allergies * IV Fluid Delivery Rate * IV Medication Dose * Pulse Rate * Bispectral Parameters * Monitored Events * Right Atrial Pressure * Left Atrial Pressure » Laboratory Data, including o Blood Gas o Chemistry o Hematology o Coagulation » Hemodynamic Calculated Values » Medications * IV Volume Infused * ETCO2 » Fractional Inspired Concentration O2, CO2 » Case Consumption Liquid Medications » Case Consumption Respiratory Gas Contraindications: There are no contraindications. Warning: AirStrip ONE Web with ACM is an adjunct to and not a replacement for direct viewing of the monitoring medical device(s). Precautions: AirStrip ONE Web with ACM requires an internet or cellular connection to provide data. AirStrip ONE Web with ACM is not intended for use where cellular telephones or other wireless devices are prohibited.

Source page: https://510kreport.com/device/K211949
Methodology: https://510kreport.com/methodology