510(k) · Cleared
ClearedPrevisEA Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Entac Medical, Inc. · DQD Stethoscope, Electronic
Cleared on Aug 4, 2021 as substantially equivalent to K150782 (Gi Logic, Inc., 2015) after a 114-day review. Its family tree reaches back 8 generations to 1996. 1 later device descends from it.
- Decided
- Aug 4, 2021
- Review
- 114 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K952882 (1996). 15 ancestors in all, the oldest K771653 (1977). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK952882 Personal Telemedicine SystemAmerican Telecare, Inc. · 1996
- 7 generations backK964554 Personal Telemedicine ModuleAmerican Telecare, Inc. · 1996
- 6 generations backK973873 Digital Personal Telemedicine Module, Digital PTM 1American Telecare, Inc. · 1997
- 5 generations backK034046 RNK Telephonic Stethoscope, Model TR-1Rnk Products · 2004
- 4 generations backK072026 RNK Electronic StethoscopeRnk Products, Inc. · 2007
- 3 generations backK102893 PCP/PC StethoscopeRnk Products, Inc. · 2011
- 2 generations backK132560 PCP-Usb StethoscopeRnk Products, Inc. · 2013
- 1 generation backK150782 AbStats GatewayGi Logic, Inc. · 2015
- This deviceK211068 PrevisEA DeviceEntac Medical, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK230769 PrevisEA DeviceEntac Medical, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K230769PrevisEA DeviceEntac Medical, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K952882 | Personal Telemedicine System | American Telecare, Inc. | 1996 | — |
| −7 | K964554 | Personal Telemedicine Module | American Telecare, Inc. | 1996 | — |
| −6 | K973873 | Digital Personal Telemedicine Module, Digital PTM 1 | American Telecare, Inc. | 1997 | — |
| −5 | K034046 | RNK Telephonic Stethoscope, Model TR-1 | Rnk Products | 2004 | — |
| −4 | K072026 | RNK Electronic Stethoscope | Rnk Products, Inc. | 2007 | — |
| −3 | K102893 | PCP/PC Stethoscope | Rnk Products, Inc. | 2011 | — |
| −2 | K132560 | PCP-Usb Stethoscope | Rnk Products, Inc. | 2013 | — |
| −1 | K150782 | AbStats Gateway | Gi Logic, Inc. | 2015 | — |
| 0 (this device) | K211068 | PrevisEA Device | Entac Medical, Inc. | 2021 | — |
| +1 | K230769 | PrevisEA Device | Entac Medical, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 DQD? 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 DQD device
- #1 K200776 Eko COREscore 25.2 · 8 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 |
|---|---|---|---|
| * | K150782 | AbStats GatewaySummary page 4…D Regulatory Class 2 Prescription Status Prescription Device Classification Panel Gastroenterology Predicate Device K150782 GI Logic AbStats® Gateway Description of Device PrevisEA is a non-invasive, self-contained, medical devic… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230769 | PrevisEA Device | 2023 | 0 |
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 25 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K230769 (Entac Medical, Inc., 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DQD devicesDQD Stethoscope, Electronic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · DQD
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQD
89in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQD
No recall names DQD since 2007.
Adverse event reports per year · DQD
1in 2024
MAUDE reports naming product code DQD, 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 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 6 | 161 | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 4 | 107 | 0 | 1 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 5 | 70 | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 3 | 250 | 0 | 0 |
| 2017 | 4 | 109 | 0 | 0 |
| 2018 | 4 | 131 | 0 | 0 |
| 2019 | 4 | 262 | 0 | 0 |
| 2020 | 6 | 104 | 0 | 0 |
| 2021 | 4 | 137 | 0 | 0 |
| 2022 | 8 | 203 | 0 | 0 |
| 2023 | 10 | 132 | 0 | 0 |
| 2024 | 4 | 153 | 0 | 1 |
| 2025 | 3 | 89 | 0 | 0 |
| 2026 | 6 | 236 | 0 | — |
What is it indicated for?
PrevisEA is a compact, non-invasive device placed on the abdomen to capture the digestive sounds of patients. PrevisEA displays information which assists physicians in assessing the digestive health of patients. This device is for prescription use only and should be used under the direction of a licensed healthcare practitioner. The PrevisEA device has not been tested for and it is not intended for pediatric use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211068 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211068: PrevisEA Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211068
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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