510(k) · Cleared
ClearedDictum Health
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dictum Health, Inc. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Feb 9, 2016 as substantially equivalent to K152124 (Remote Diagnostics Technologies, Ltd., 2015) after a 146-day review. Its family tree reaches back 7 generations to 1987. 6 later devices descend from it.
- Decided
- Feb 9, 2016
- Review
- 146 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K864318 (1987). 26 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 6 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 5 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 4 generations backK033410 Tempus 2000 Patient Monitor, Model 00-0002Remote Diagnostic Technologies, Ltd. · 2004
- 3 generations backK082718 Tempusic Patient MonitorRemote Diagnostic Technologies, Ltd. · 2008
- 2 generations backK113105 Tempusic Patient MonitorRemote Diagnostic Technologies, Ltd. · 2011
- 1 generation backK152124 Tempus IC2Remote Diagnostics Technologies, Ltd. · 2015
- This deviceK152645 Dictum HealthDictum Health, Inc. · 2016
- Descendant · cites it directly · 5 of its ownK170798 Dictum HealthDictum Health, Inc. · 2017
- Descendant · 2 generations on · 4 of its ownK192004 Eko Analysis SoftwareEko Devices, Inc. · 2020
- Descendant · 3 generations on · 3 of its ownK213794 Eko Murmur Analysis Software (EMAS)Eko Devices, Inc. · 2022
- Descendant · 4 generations on · 1 of its ownK240901 StethophoneSparrow Acoustics, Inc. · 2024
- Descendant · 5 generations on · 0 of its ownK252595 Stethophone ProSparrow Acoustics, Inc. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K170798Dictum HealthDictum Health, Inc. · 2017 · cites it directly5descendants
- K192004Eko Analysis SoftwareEko Devices, Inc. · 2020 · 2 generations on4descendants
- K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc. · 2022 · 3 generations on3descendants
- K240901StethophoneSparrow Acoustics, Inc. · 2024 · 4 generations on1descendant
- K252595Stethophone ProSparrow Acoustics, Inc. · 2025 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −6 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −5 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −4 | K033410 | Tempus 2000 Patient Monitor, Model 00-0002 | Remote Diagnostic Technologies, Ltd. | 2004 | — |
| −3 | K082718 | Tempusic Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2008 | — |
| −2 | K113105 | Tempusic Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2011 | — |
| −1 | K152124 | Tempus IC2 | Remote Diagnostics Technologies, Ltd. | 2015 | — |
| 0 (this device) | K152645 | Dictum Health | Dictum Health, Inc. | 2016 | — |
| +1 | K170798 | Dictum Health | Dictum Health, Inc. | 2017 | — |
| +2 | K192004 | Eko Analysis Software | Eko Devices, Inc. | 2020 | — |
| +3 | K213794 | Eko Murmur Analysis Software (EMAS) | Eko Devices, Inc. | 2022 | — |
| +4 | K240901 | Stethophone | Sparrow Acoustics, Inc. | 2024 | — |
| +5 | K252595 | Stethophone Pro | Sparrow Acoustics, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1995 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K152124 | Tempus IC2 Cleared while this submission was under review Summary page 4…rer Name of the Predicate Device FDA 510(k) # Regulation/Product Code Remote Diagnostics Tempus IC2 K152124 21 CFR 870.2300/MWI Technologies LTD 3. Indications for Use (intended use): The IDM100 for use by clinicians and… | 2015 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170798 | Dictum Health | 2017 | 5 |
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?
- The line of descent spans 29 years and passes through 6 companies; a new generation was cleared every 3.9 years on median.
- 2 of the 26 ancestors have a recall of any class.
- Of its descendants, K170798 (Dictum Health, Inc., 2017) has gone furthest, with 5 descendants of its own.
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. 2016, 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 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…
Read the full statement (214 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152645 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152645: Dictum Health.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152645
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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