510(k) · Cleared
ClearedAirStrip ONE Web Client with Alarm Communication Management (ACM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Airstrip Technologies, Inc. · MSX System, Network And Communication, Physiological Monitors
Cleared on Dec 9, 2021 as substantially equivalent to K160862 (Airstrip Technologies, Inc., 2016) after a 169-day review. Its family tree reaches back 1 generation to 2016.
- Decided
- Dec 9, 2021
- Review
- 169 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K160862 (2016). No later device cites it as a predicate yet.
- Root · 1 generation backK160862 AirStrip RPMAirstrip Technologies, Inc. · 2016
- This deviceK211949 AirStrip ONE Web Client with Alarm Communication Management (ACM)Airstrip Technologies, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K160862 | AirStrip RPM | Airstrip Technologies, Inc. | 2016 | — |
| 0 (this device) | K211949 | AirStrip ONE Web Client with Alarm Communication Management (ACM) | Airstrip Technologies, Inc. | 2021 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MSX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MSX device
- #1 K242750 Central Stationscore 21.5 · 31 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K160862 | AirStrip RPMSummary page 5…rip Model Predicate Predicate Equivalent Devices: 510(k) Number Manufacturer / Model AirStrip ONE Web K160862 AirStrip Technologies, Inc. / Client with Alarm AirStrip ONE Web Client… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K160862.
How does its category compare?
All MSX devicesMSX System, Network And Communication, Physiological Monitors: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · MSX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MSX
295in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSX
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MSX
19in 2025
MAUDE reports naming product code MSX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 58 | 1 | 5 |
| 2008 | 1 | — | 1 | 6 |
| 2009 | 1 | — | 2 | 7 |
| 2010 | 3 | 43 | 1 | 14 |
| 2011 | 7 | 72 | 1 | 3 |
| 2012 | 4 | 145 | 2 | 4 |
| 2013 | 2 | — | 0 | 17 |
| 2014 | 3 | 165 | 0 | 32 |
| 2015 | 5 | 138 | 2 | 31 |
| 2016 | 3 | 174 | 0 | 11 |
| 2017 | 2 | — | 2 | 16 |
| 2018 | 4 | 111 | 1 | 15 |
| 2019 | 4 | 92 | 0 | 15 |
| 2020 | 5 | 193 | 0 | 25 |
| 2021 | 3 | 227 | 0 | 17 |
| 2022 | 5 | 177 | 1 | 18 |
| 2023 | 3 | 244 | 0 | 10 |
| 2024 | 4 | 212 | 0 | 32 |
| 2025 | 4 | 295 | 1 | 19 |
| 2026 | 5 | 145 | 2 | — |
What is it indicated for?
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…
Read the full statement (546 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211949 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211949: AirStrip ONE Web Client with Alarm Communication Management (ACM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211949
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026