510(k) · Cleared
ClearedAirstrip Remote Patient Monitoring
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 Feb 14, 2014 after a 95-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Feb 14, 2014
- Review
- 95 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK133450 Airstrip Remote Patient MonitoringAirstrip Technologies, LP · 2014
- Descendant · cites it directly · 1 of its ownK151839 AMC Health VitalCaregiving SystemAmc Health · 2016
- Descendant · cites it directly · 0 of its ownK233446 AMC Health CareConsoleAmc Health · 2024
- Descendant · cites it directly · 0 of its ownK182226 AirStrip RPM InvisionHeart AdapterAirstrip Technologies, Inc. · 2018
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K133450 | Airstrip Remote Patient Monitoring | Airstrip Technologies, LP | 2014 | — |
| +1 | K151839 | AMC Health VitalCaregiving System | Amc Health | 2016 | — |
| +1 | K233446 | AMC Health CareConsole | Amc Health | 2024 | — |
| +1 | K182226 | AirStrip RPM InvisionHeart Adapter | Airstrip Technologies, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
3 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, K151839 (Amc Health, 2016) has gone furthest, with 1 descendant 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. 2014, 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 phy/siologic 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 phy/siologic 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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K133450 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133450: Airstrip Remote Patient Monitoring.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133450
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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