# K212975: MedWand

- Pathway: 510(k) (Traditional)
- Applicant: Medwand Solutions, Inc.
- Decided: Jul 22, 2022 after 308 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: 14 generations back to K941811 (1994). 148 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 150 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210086: Vitals360 Multi-Vitals Mobile Monitor, Vocare, Inc. (2021) Summary page 5.
- K210736: doctorgram Stethoscope DES-I, Gv Concepts (2021) Summary page 5.

## Most influential descendants
- K253436: c-med0 alpha (2026), 0 descendants of its own

## Indications for use
The MedWand™ Device, in combination with the MedWand™ Software Application installed on an attached mobile device or computing system, is an intermittent vital sign measuring and examination system intended to collect, record, and display the following information: • Oxygen saturation (SpO2), • Pulse rate (PR), • Infrared body temperature (TEMP) • Amplified auscultation sounds filtered for heart, lungs, and abdomen (STETH) • Photographs of areas needing assessment (CAMERA) The device is intended for use by adult lay users independently or guided by a health care professional (HCP) in home and non-acute clinical environments. The MedWand™ Device is intended for use by trained adults only who can use smart phones, tablets, or computers proficiently. Collected information is not intended for self-diagnosis. Interpretation and assessment of results should be performed by an HCP. Collected information can be provided to a HCP when used as a standalone device. Additionally, the MedWand™ Device can integrate with external data communications systems (not part of the MedWand™ Device) through a programming interface. This integration will facilitate interactions between the lay user and HCP for telemedicine. The device is intended for spot-checking and does not have continuous monitoring capability or alarm features.

Source page: https://510kreport.com/device/K212975
Methodology: https://510kreport.com/methodology