# K160862: AirStrip RPM

- Pathway: 510(k) (Traditional)
- Applicant: Airstrip Technologies, Inc.
- Decided: Sep 19, 2016 after 174 days
- Product code: MSX (System, Network And Communication, Physiological Monitors)
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K181196: Caretaker Remote Display App and Caretaker Software Library (2018), 1 descendant of its own
- K230214: Huma RPM (RPM) (2023), 0 descendants of its own
- K211949: AirStrip ONE Web Client with Alarm Communication Management (ACM) (2021), 0 descendants of its own
- K211588: Caretaker Platform, VitalStream Platform, CT5 (2021), 0 descendants of its own

## Indications for use
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

Source page: https://510kreport.com/device/K160862
Methodology: https://510kreport.com/methodology