510(k) · Cleared
ClearedHuma RPM (RPM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medopad, Inc. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Jun 2, 2023 as substantially equivalent to K122133 (Airstrip Technologies, LP, 2012) and 1 other predicate after a 127-day review. Its family tree reaches back 1 generation to 2012.
- Decided
- Jun 2, 2023
- Review
- 127 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K122133 (2012). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK122133 Airstrip Remote Patient Monitoring (RPM) Remote Data ViewingAirstrip Technologies, LP · 2012
- This deviceK230214 Huma RPM (RPM)Medopad, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K122133 | Airstrip Remote Patient Monitoring (RPM) Remote Data Viewing | Airstrip Technologies, LP | 2012 | — |
| 0 (this device) | K230214 | Huma RPM (RPM) | Medopad, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 |
|---|---|---|---|
| * | K122133 | Airstrip Remote Patient Monitoring (RPM) Remote Data ViewingSummary page 4…TE DEVICES Predicates: AirStrip Remote Patient Monitoring (RPM) and Web Client (1) AirStrip Remote Patient Monitoring (RPM) Remote Data Viewing, cleared under K122133, by AirStrip Technologies (2) AirStrip One Web Client, cleared under K160862, by AirStrip Technologies… | 2012 |
| * | K160862 | AirStrip RPMSummary page 4…(1) AirStrip Remote Patient Monitoring (RPM) Remote Data Viewing, cleared under K122133, by AirStrip Technologies (2) AirStrip One Web Client, cleared under K160862, by AirStrip Technologies 1 of 10… | 2016 |
| † | K211949 | AirStrip ONE Web Client with Alarm Communication Management (ACM) | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
- 3 other devices also cite its predicate K122133.
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. 2023, 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?
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…
Read the full statement (273 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230214 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230214: Huma RPM (RPM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230214
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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