510(k) · Cleared
ClearedAirStrip RPM
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 Sep 19, 2016 after a 174-day review. The FDA summary names no predicate by number. 4 later devices descend from it.
- Decided
- Sep 19, 2016
- Review
- 174 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK160862 AirStrip RPMAirstrip Technologies, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK181196 Caretaker Remote Display App and Caretaker Software LibraryCaretaker Medical, LLC · 2018
- Descendant · cites it directly · 0 of its ownK230214 Huma RPM (RPM)Medopad, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK211949 AirStrip ONE Web Client with Alarm Communication Management (ACM)Airstrip Technologies, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK211588 Caretaker Platform, VitalStream Platform, CT5Caretaker Medical · 2021
Most influential descendants
Showing 4 of 4 · See all- K181196Caretaker Remote Display App and Caretaker Software LibraryCaretaker Medical, LLC · 2018 · cites it directly1descendant
- K230214Huma RPM (RPM)Medopad, Inc. · 2023 · cites it directly0descendants
- K211949AirStrip ONE Web Client with Alarm Communication Management (ACM)Airstrip Technologies, Inc. · 2021 · cites it directly0descendants
- K211588Caretaker Platform, VitalStream Platform, CT5Caretaker Medical · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K160862 | AirStrip RPM | Airstrip Technologies, Inc. | 2016 | — |
| +1 | K181196 | Caretaker Remote Display App and Caretaker Software Library | Caretaker Medical, LLC | 2018 | — |
| +1 | K230214 | Huma RPM (RPM) | Medopad, Inc. | 2023 | — |
| +1 | K211949 | AirStrip ONE Web Client with Alarm Communication Management (ACM) | Airstrip Technologies, Inc. | 2021 | — |
| +2 | K211588 | Caretaker Platform, VitalStream Platform, CT5 | Caretaker Medical | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 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 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?
The FDA summary names no predicate by number.
What descends from it? (4)
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, K181196 (Caretaker Medical, LLC, 2018) has gone furthest, with 1 descendant of its own.
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. 2016, 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?
information is generated by other medical devices and patient information system, and not by this device. This device captures this information from these other systems and displays it for clinicians. This device is intended to be used by clinicians for the following purposes: • 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…
Read the full statement (162 words)
information is generated by other medical devices and patient information system, and not by this device. This device captures this information from these other systems and displays it for clinicians.
This device is intended to be used by clinicians for the following purposes:
• 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
This device 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
• Systolic Blood Pressure Invasive
• Mean Arterial Pressure Invasive
• Diastolic Blood Pressure Invasive
• Systolic Blood Pressure Cuff
• Mean Arterial Pressure Cuff
• Diastolic Blood Pressure Cuff
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160862 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160862: AirStrip RPM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160862
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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