510(k) · Cleared
ClearedAirstrip Remote Patient Monitoring (RPM) Remote Data Viewing Software, Version 3.1
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 Jul 23, 2010 as substantially equivalent to K061994 (GE Healthcare, 2006) and 1 other predicate after a 185-day review. Its family tree reaches back 1 generation to 2006. 6 later devices descend from it.
- Decided
- Jul 23, 2010
- Review
- 185 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K061994 (2006). 2 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK061994 Web Viewer, Pocket Viewer and Cellular Viewer with L- WEB05 SoftwareGE Healthcare · 2006 · Recalled
- This deviceK100133 Airstrip Remote Patient Monitoring (RPM) Remote Data Viewing…Airstrip Technologies, LP · 2010
- Descendant · cites it directly · 5 of its ownK142106 Decisio Health Patient DashboardDecisio Health, Inc. · 2015
- Descendant · 2 generations on · 3 of its ownK213335 Capsule Surveillance SystemCapsule Surveillance Technologies, Sas /Capsule Tech, Inc. · 2022
- Descendant · 3 generations on · 0 of its ownK241958 WARD-CSS (v1.2.x)Ward 24/7 Aps · 2025
- Descendant · 3 generations on · 0 of its ownK240756 Aitrics-VCAitrics Co., Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK233133 Talis EMR with Talis +ACG (Talis EMR with +ACG)Talis Clinical, LLC · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K142106Decisio Health Patient DashboardDecisio Health, Inc. · 2015 · cites it directly5descendants
- K213335Capsule Surveillance SystemCapsule Surveillance Technologies, Sas /Capsule Tech, Inc. · 2022 · 2 generations on3descendants
- K241958WARD-CSS (v1.2.x)Ward 24/7 Aps · 2025 · 3 generations on0descendants
- K240756Aitrics-VCAitrics Co., Ltd. · 2024 · 3 generations on0descendants
- K233133Talis EMR with Talis +ACG (Talis EMR with +ACG)Talis Clinical, LLC · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K061994 | Web Viewer, Pocket Viewer and Cellular Viewer with L- WEB05 Software | GE Healthcare | 2006 | 1 |
| 0 (this device) | K100133 | Airstrip Remote Patient Monitoring (RPM) Remote Data Viewing Software, Version… | Airstrip Technologies, LP | 2010 | — |
| +1 | K142106 | Decisio Health Patient Dashboard | Decisio Health, Inc. | 2015 | — |
| +2 | K213335 | Capsule Surveillance System | Capsule Surveillance Technologies, Sas /Capsule Tech, Inc. | 2022 | — |
| +3 | K241958 | WARD-CSS (v1.2.x) | Ward 24/7 Aps | 2025 | — |
| +3 | K240756 | Aitrics-VC | Aitrics Co., Ltd. | 2024 | — |
| +3 | K233133 | Talis EMR with Talis +ACG (Talis EMR with +ACG) | Talis Clinical, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 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? (2)
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 |
|---|---|---|---|
| * | K061994 | Web Viewer, Pocket Viewer and Cellular Viewer with L- WEB05 SoftwareSummary page 1…Cosmetic Act for remote data viewing of cardiovascular data. Predicate Devices: GE Pocket Viewer (K061994) Cerner iBus (K093 134) Device Description Airstrip RPM issoftware that runs on devices… | 2006 |
| * | K093134 | Cerner Careaware IbusSummary page 1…ar data. Predicate Devices: GE Pocket Viewer (K061994) Cerner iBus (K093 134) Device Description Airstrip RPM issoftware that runs on devices capable of running Apple iPhone OS. It interfaces with third-pa… | 2009 |
| † | K033078 | Datex Ohmeda S/5 Web Viewer and S/5 Pocket Viewer with L-WEB03 Software | 2003 |
| † | K000647 | Datex-Ohmeda Network and Central | 2000 |
| † | K013387 | Datex-Ohmeda S/5 Web Viewer | 2002 |
| † | K023497 | Datex-Ohmeda S/5 Web Viewer with L-6WV02 Software | 2002 |
| † | K992323 | Datex-Ohmeda Cardiocap 5, F-MX, F-MXG and Accessories | 1999 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142106 | Decisio Health Patient Dashboard | 2015 | 5 |
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?
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. 2010, 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 (312 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 patient's waveform or other data
The AirStrip RPM software can display the following the physiologic data captured by other medical devices:
* 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
o Blood Gas
o Chemistry
o Hematology
o Coagulation
* Allergies
* Medications
Contraindications
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/K100133 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100133: Airstrip Remote Patient Monitoring (RPM) Remote Data Viewing Software, Version 3.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100133
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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