510(k) · Cleared
ClearedEdentec Model 3711 Digital Recorder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edentec Corp. · DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Cleared on Aug 29, 1991 after a 181-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 98 later devices descend from it.
- Decided
- Aug 29, 1991
- Review
- 181 days
- Class
- Class II
- Product code
- DRT
- Recalls
- None
- Predicates
- 0
98 later devices descend from it, 1 citing it directly.
- This deviceK910870 Edentec Model 3711 Digital RecorderEdentec Corp. · 1991
- Descendant · cites it directly · 97 of its ownK963597 Silent Night ILocal Silence, Inc. · 1997
- Descendant · 2 generations on · 96 of its ownK981034 Silent Night IISleep Solutions, Inc. · 1998
- Descendant · 3 generations on · 69 of its ownK000253 Silent Night VSleep Solutions, Inc. · 2000
- Descendant · 4 generations on · 63 of its ownK042745 Lifescreen ApneaDel Mar Reynolds Medical, Inc. · 2005 · Recalled
- Descendant · 5 generations on · 53 of its ownK083325 N-600X with SPD, Oximax N-600XCovidien · 2009
Showing 5 of 98 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 98 · See all- K963597Silent Night ILocal Silence, Inc. · 1997 · cites it directly97descendants
- K981034Silent Night IISleep Solutions, Inc. · 1998 · 2 generations on96descendants
- K000253Silent Night VSleep Solutions, Inc. · 2000 · 3 generations on69descendants
- K042745Lifescreen ApneaDel Mar Reynolds Medical, Inc. · 2005 · 4 generations on63descendants
- K083325N-600X with SPD, Oximax N-600XCovidien · 2009 · 5 generations on53descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K910870 | Edentec Model 3711 Digital Recorder | Edentec Corp. | 1991 | — |
| +1 | K963597 | Silent Night I | Local Silence, Inc. | 1997 | — |
| +2 | K981034 | Silent Night II | Sleep Solutions, Inc. | 1998 | — |
| +3 | K000253 | Silent Night V | Sleep Solutions, Inc. | 2000 | — |
| +4 | K042745 | Lifescreen Apnea | Del Mar Reynolds Medical, Inc. | 2005 | 1 |
| +5 | K083325 | N-600X with SPD, Oximax N-600X | Covidien | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 5 | 0 |
| 2016 | 4 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 15 | 0 |
| 2023 | 4 | 0 |
| 2024 | 8 | 0 |
| 2025 | 14 | 0 |
| 2026 | 7 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DRT? 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 DRT device
- #1 K252676 The Circadia C300 System (C300)score 15.3 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (98)
See all 981 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K963597 | Silent Night I | 1997 | 97 |
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?
- Of its descendants, K963597 (Local Silence, Inc., 1997) has gone furthest, with 97 descendants of its own.
How does its category compare?
All DRT devicesDRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRT
228in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRT
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRT
40in 2025
MAUDE reports naming product code DRT, 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 | 1 | — | 0 | 113 |
| 2008 | 1 | — | 0 | 99 |
| 2009 | 6 | 70 | 0 | 118 |
| 2010 | 3 | 44 | 0 | 63 |
| 2011 | 3 | 149 | 1 | 36 |
| 2012 | 1 | — | 0 | 47 |
| 2013 | 1 | — | 0 | 16 |
| 2014 | 0 | — | 0 | 26 |
| 2015 | 1 | — | 0 | 48 |
| 2016 | 1 | — | 0 | 55 |
| 2017 | 1 | — | 0 | 159 |
| 2018 | 1 | — | 0 | 224 |
| 2019 | 1 | — | 0 | 447 |
| 2020 | 0 | — | 0 | 50 |
| 2021 | 2 | — | 1 | 85 |
| 2022 | 1 | — | 0 | 35 |
| 2023 | 1 | — | 0 | 47 |
| 2024 | 3 | 228 | 1 | 29 |
| 2025 | 1 | — | 0 | 40 |
| 2026 | 5 | 120 | 0 | — |
https://510kreport.com/device/K910870 · printed Nov 6, 2026
Cite this page
510(k) Report. “K910870: Edentec Model 3711 Digital Recorder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K910870
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026