# K170798: Dictum Health

- Pathway: 510(k) (Abbreviated)
- Applicant: Dictum Health, Inc.
- Decided: Jul 14, 2017 after 119 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: 8 generations back to K864318 (1987). 37 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152645: Dictum Health, Dictum Health, Inc. (2016) Summary page 4.
- K072979: Spirobank G, Mir Medical Intl. Research Srl (2007) Summary page 8.

## Most influential descendants
- 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
- K251494: Eko Foundation Analysis Software with Transformers (EFAST) (2025), 0 descendants of its own

## Indications for use
The IDM100 is 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, except as noted below), adolescent (between 13 years and 17 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 via secured video conferencing. The IDM100 is not intended for continuous 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. ECG calculation of diagnostic measurements is provided for adult patients only. • Non-invasive blood pressure (NIBP) automatically measures systolic and diastolic pressure and pulse rate, while calculating mean arterial pressure (MAP). The equation used to calculate MAP provides an approximate value. • 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), pulse rate, and optional Respiratory Rate. • Electronic Stethoscope for acquiring and monitoring of auscultation signals from the attached chest piece. • Spirometry captures, displays, stores, and compares pulmonary function measures and waveforms. The spirometer should only be used with patients able to understand and perform the testing instructions. Indicated for use on pediatric, adolescent, and adult patients only. Patients must be six years of age or older. Administration of the spirometry test must be performed by a health care professional (HCP) who is physically with the test subject. Spirometry tests are not to be administered by a patient. • Screening hearing test using pure tone method. Indicated for pediatric, adolescent and adult only. Patients must be six years of age or older. The administration of the hearing test must be performed by a health care professional (HCP) who is physically with the test subject. . Audiometry tests (hearing tests) are not to be administered by a patient. • Manual interface for height, weight, respiratory rate, and other manually captured patient information.

Source page: https://510kreport.com/device/K170798
Methodology: https://510kreport.com/methodology