510(k) · Cleared
ClearedAbStats Gateway
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gi Logic, Inc. · DQD Stethoscope, Electronic
Cleared on Dec 14, 2015 as substantially equivalent to K132560 (Rnk Products, Inc., 2013) after a 264-day review. Its family tree reaches back 7 generations to 1996. 2 later devices descend from it.
- Decided
- Dec 14, 2015
- Review
- 264 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K952882 (1996). 14 ancestors in all, the oldest K771653 (1977). 2 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK952882 Personal Telemedicine SystemAmerican Telecare, Inc. · 1996
- 6 generations backK964554 Personal Telemedicine ModuleAmerican Telecare, Inc. · 1996
- 5 generations backK973873 Digital Personal Telemedicine Module, Digital PTM 1American Telecare, Inc. · 1997
- 4 generations backK034046 RNK Telephonic Stethoscope, Model TR-1Rnk Products · 2004
- 3 generations backK072026 RNK Electronic StethoscopeRnk Products, Inc. · 2007
- 2 generations backK102893 PCP/PC StethoscopeRnk Products, Inc. · 2011
- 1 generation backK132560 PCP-Usb StethoscopeRnk Products, Inc. · 2013
- This deviceK150782 AbStats GatewayGi Logic, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK211068 PrevisEA DeviceEntac Medical, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK230769 PrevisEA DeviceEntac Medical, Inc. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K952882 | Personal Telemedicine System | American Telecare, Inc. | 1996 | — |
| −6 | K964554 | Personal Telemedicine Module | American Telecare, Inc. | 1996 | — |
| −5 | K973873 | Digital Personal Telemedicine Module, Digital PTM 1 | American Telecare, Inc. | 1997 | — |
| −4 | K034046 | RNK Telephonic Stethoscope, Model TR-1 | Rnk Products | 2004 | — |
| −3 | K072026 | RNK Electronic Stethoscope | Rnk Products, Inc. | 2007 | — |
| −2 | K102893 | PCP/PC Stethoscope | Rnk Products, Inc. | 2011 | — |
| −1 | K132560 | PCP-Usb Stethoscope | Rnk Products, Inc. | 2013 | — |
| 0 (this device) | K150782 | AbStats Gateway | Gi Logic, Inc. | 2015 | — |
| +1 | K211068 | PrevisEA Device | Entac Medical, Inc. | 2021 | — |
| +2 | 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 |
|---|---|---|
| 2021 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K132560 | PCP-Usb StethoscopeSummary page 4…Stethoscope (21 CFR 870.1875) Regulatory Class: Class II Product Code: DQD Predicate Device: RNK PCP-USB Stethoscope (K132560) Device Description: The AbStats Gateway is a compact device with integrated sensor interfaces and embedded computing system (st… | 2013 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211068 | PrevisEA Device | 2021 | 1 |
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 19 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K211068 (Entac Medical, Inc., 2021) has gone furthest, with 1 descendant 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. 2015, 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?
The AbStats Gateway is a compact device with integrated sensor interfaces and embedded computing system (stethoscope) that in conjunction with external sensors constitutes the AbStats system. The AbStats system external sensors are placed on the abdomen and identify the vibratory signals associated with digestive processes. This device should be used under the direction of a licensed healthcare practitioner when it is required to determine this patient digestive state. The 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/K150782 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150782: AbStats Gateway.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150782
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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