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 May 19, 2023 as substantially equivalent to K211068 (Entac Medical, Inc., 2021) after a 60-day review. Its family tree reaches back 9 generations to 1996.
- Decided
- May 19, 2023
- Review
- 60 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K952882 (1996). 16 ancestors in all, the oldest K771653 (1977). No later device cites it as a predicate yet.
- Root · 9 generations backK952882 Personal Telemedicine SystemAmerican Telecare, Inc. · 1996
- 5 generations between
- 3 generations backK132560 PCP-Usb StethoscopeRnk Products, Inc. · 2013
- 2 generations backK150782 AbStats GatewayGi Logic, Inc. · 2015
- 1 generation backK211068 PrevisEA DeviceEntac Medical, Inc. · 2021
- This deviceK230769 PrevisEA DeviceEntac Medical, Inc. · 2023
Show all 9 generations
- Root · 9 generations backK952882 Personal Telemedicine SystemAmerican Telecare, Inc. · 1996
- 8 generations backK964554 Personal Telemedicine ModuleAmerican Telecare, Inc. · 1996
- 7 generations backK973873 Digital Personal Telemedicine Module, Digital PTM 1American Telecare, Inc. · 1997
- 6 generations backK034046 RNK Telephonic Stethoscope, Model TR-1Rnk Products · 2004
- 5 generations backK072026 RNK Electronic StethoscopeRnk Products, Inc. · 2007
- 4 generations backK102893 PCP/PC StethoscopeRnk Products, Inc. · 2011
- 3 generations backK132560 PCP-Usb StethoscopeRnk Products, Inc. · 2013
- 2 generations backK150782 AbStats GatewayGi Logic, Inc. · 2015
- 1 generation backK211068 PrevisEA DeviceEntac Medical, Inc. · 2021
- This deviceK230769 PrevisEA DeviceEntac Medical, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K952882 | Personal Telemedicine System | American Telecare, Inc. | 1996 | — |
| −8 | K964554 | Personal Telemedicine Module | American Telecare, Inc. | 1996 | — |
| −7 | K973873 | Digital Personal Telemedicine Module, Digital PTM 1 | American Telecare, Inc. | 1997 | — |
| −6 | K034046 | RNK Telephonic Stethoscope, Model TR-1 | Rnk Products | 2004 | — |
| −5 | K072026 | RNK Electronic Stethoscope | Rnk Products, Inc. | 2007 | — |
| −4 | K102893 | PCP/PC Stethoscope | Rnk Products, Inc. | 2011 | — |
| −3 | K132560 | PCP-Usb Stethoscope | Rnk Products, Inc. | 2013 | — |
| −2 | K150782 | AbStats Gateway | Gi Logic, Inc. | 2015 | — |
| −1 | K211068 | PrevisEA Device | Entac Medical, Inc. | 2021 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K211068 | PrevisEA DeviceSummary page 4…DQD Regulatory Class 2 Prescription Status Prescription Device Classification Panel Gastroenterology Predicate Device K211068 PrevisEATM Device Description of Device PrevisEA is a non-invasive, self-contained, medical device with a pr… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- None of the 16 ancestors has a recall.
How does its category compare?
All DQD devicesDQD Stethoscope, Electronic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 as stated in the FDA summary.
https://510kreport.com/device/K230769 · printed Nov 5, 2026
Cite this page
510(k) Report. “K230769: PrevisEA Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K230769
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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