# K152645: Dictum Health

- Pathway: 510(k) (Abbreviated)
- Applicant: Dictum Health, Inc.
- Decided: Feb 9, 2016 after 146 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: 7 generations back to K864318 (1987). 26 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152124: Tempus IC2, Remote Diagnostics Technologies, Ltd. (2015). Cleared while this submission was under review Summary page 4.

## Most influential descendants
- K170798: Dictum Health (2017), 5 descendants of its own
- K192004: Eko Analysis Software (2020), 4 descendants of its own
- K213794: Eko Murmur Analysis Software (EMAS) (2022), 3 descendants of its own
- K240901: Stethophone (2024), 1 descendant of its own
- K252595: Stethophone Pro (2025), 0 descendants of its own

## Indications for use
The IDM100 for use by clinicians and patients to collect, store, and transmit general patient health information and patient vital signs data between the patient and a health care professional. The IDM100 is intended for use on neonate (up to 28 days), pediatric (29 days to 12 years), adolescent (>12 years & <18 years) and adult (18 years and older) populations, in the clinical setting, or a remote location such as home or clinic with the clinician interacting with the patient and/or caregiver using secured video conferencing. The product is not intended for continuous patient monitoring. Vital Sign and Cardiopulmonary Tests: • Signal acquisition and display for 12 lead ECG waveform and 3 lead rhythm: for evaluation and diagnosis of patient cardiac function. • Non-invasive blood pressure (NIBP): automatically measures systolic and diastolic pressure and pulse rate, as well as calculates an approximate mean arterial pressure (MAP). • Patient temperature: provides temperature measurements from the tympanic membrane (ear) and manual entry of oral, rectal and axillary temperatures. • SpO2 Oximeter: for the non-invasive measurement of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. • Electronic Stethoscope: for acquiring and monitoring of auscultation signals from the attached chest piece. • Manual interface for height, weight, respiratory rate, and other manually captured patient information.

Source page: https://510kreport.com/device/K152645
Methodology: https://510kreport.com/methodology