510(k) · Cleared
ClearedAirstrip Remote Patient Monitoring (RPM) Remote Data Viewing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Airstrip Technologies, LP · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Oct 2, 2012 after a 76-day review. The FDA summary names no predicate by number. 35 later devices descend from it.
- Decided
- Oct 2, 2012
- Review
- 76 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 0
35 later devices descend from it, 4 citing it directly.
- This deviceK122133 Airstrip Remote Patient Monitoring (RPM) Remote Data ViewingAirstrip Technologies, LP · 2012
- Descendant · cites it directly · 25 of its ownK130796 Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien · 2013 · Recalled
- Descendant · 2 generations on · 24 of its ownK132604 Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien · 2013 · Recalled
- Descendant · 3 generations on · 22 of its ownK140339 Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien · 2014 · Recalled
- Descendant · 3 generations on · 18 of its ownK142732 T3 SoftwareEtiometry, Inc. · 2015
- Descendant · 4 generations on · 17 of its ownK151715 T3 SoftwareEtiometry, Inc. · 2015
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K130796Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien · 2013 · cites it directly25descendants
- K132604Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien · 2013 · 2 generations on24descendants
- K140339Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien · 2014 · 3 generations on22descendants
- K142732T3 SoftwareEtiometry, Inc. · 2015 · 3 generations on18descendants
- K151715T3 SoftwareEtiometry, Inc. · 2015 · 4 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K122133 | Airstrip Remote Patient Monitoring (RPM) Remote Data Viewing | Airstrip Technologies, LP | 2012 | — |
| +1 | K130796 | Vital Sync Informatics Manager & Virtual Patient Monitoring Platform | Covidien | 2013 | 2 |
| +2 | K132604 | Vital Sync Informatics Manager & Virtual Patient Monitoring Platform | Covidien | 2013 | 2 |
| +3 | K140339 | Vital Sync Informatics Manager & Virtual Patient Monitoring Platform | Covidien | 2014 | 2 |
| +3 | K142732 | T3 Software | Etiometry, Inc. | 2015 | — |
| +4 | K151715 | T3 Software | Etiometry, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 6 | 0 |
| 2024 | 2 | 0 |
| 2025 | 5 | 0 |
| 2026 | 2 | 0 |
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 MWI? 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 MWI device
- #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (35)
See all 354 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K130796 (Covidien, 2013) has gone furthest, with 25 descendants of its own.
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 2025
MAUDE reports naming product code MWI, 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 | 9 | 42 | 1 | 3 |
| 2008 | 9 | 49 | 1 | 3 |
| 2009 | 6 | 112 | 2 | 20 |
| 2010 | 17 | 58 | 2 | 17 |
| 2011 | 11 | 78 | 3 | 16 |
| 2012 | 13 | 104 | 5 | 31 |
| 2013 | 20 | 85 | 3 | 42 |
| 2014 | 16 | 148 | 6 | 30 |
| 2015 | 19 | 127 | 1 | 31 |
| 2016 | 12 | 165 | 0 | 51 |
| 2017 | 13 | 205 | 2 | 85 |
| 2018 | 11 | 217 | 0 | 158 |
| 2019 | 14 | 255 | 4 | 169 |
| 2020 | 8 | 138 | 0 | 110 |
| 2021 | 9 | 161 | 0 | 188 |
| 2022 | 5 | 231 | 2 | 168 |
| 2023 | 8 | 250 | 0 | 179 |
| 2024 | 10 | 202 | 5 | 120 |
| 2025 | 4 | 247 | 0 | 182 |
| 2026 | 6 | 239 | 9 | — |
What is it indicated for?
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…
Read the full statement (314 words)
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 patients 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
Counter-indications
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122133 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122133: Airstrip Remote Patient Monitoring (RPM) Remote Data Viewing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122133
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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