# K230214: Huma RPM (RPM)

- Pathway: 510(k) (Traditional)
- Applicant: Medopad, Inc.
- Decided: Jun 2, 2023 after 127 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- 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
Longest line of descent: 1 generation back to K122133 (2012). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122133: Airstrip Remote Patient Monitoring (RPM) Remote Data Viewing, Airstrip Technologies, LP (2012) Summary page 4.
- K160862: AirStrip RPM, Airstrip Technologies, Inc. (2016) Summary page 4.

## Indications for use
The Huma platform is a modular software as a medical device (SaMD) which may utilize compatible devices and software to obtain data collated via a mobile app or web app and delivered to the clinician via a web portal or web app where it may be viewed to drive clinical management. It is intended to be used for the physiological and non-physiological intermittent or spot-check monitoring of all condition patients in professional healthcare facilities, such as clinics, hospitals or skilled nursing facilities, or in the patient's home setting. It is intended for the monitoring of patients by trained healthcare professionals. The Huma platform comprises a number of different modules and functionalities that can be selected by the customer for configuration of care plans which can be further personalized for the patients. Clinical information collected from these modules is displayed on a clinician web portal and patient app with the addition of flagging out of range datasets, trend visualization, goal setting and communication channels between clinicians and patients. The data displayed on the mobile app, web portal or web app can be labeled, flagged and triaged for the purposes of monitoring disease or deterioration, improvement and to support clinical decision making and to encourage self-management of disease by the patients. The platform may also provide data analytics, risk scores and static algorithms that may assist in the assessment of risk prediction, diagnosis, disease monitoring and prognostication. The Huma platform can be used for adult and pediatric populations with functionality to accommodate data entry by caregivers and guardians. The Huma platform is not intended for use in high-acuity environments, such as ICU or operating rooms.

Source page: https://510kreport.com/device/K230214
Methodology: https://510kreport.com/methodology