De Novo · Granted
GrantedEnlight 1810
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Timpel, Inc. · QEB Ventilatory Electrical Impedance Tomograph
Granted on Dec 20, 2018 as a new device type through De Novo after a 447-day review. 5 later devices descend from it.
- Decided
- Dec 20, 2018
- Review
- 447 days
- Class
- Class II
- Product code
- QEB
- Recalls
- None
5 later devices descend from it, 1 citing it directly.
- This deviceDEN170072 Enlight 1810Timpel, Inc. · 2018
- Descendant · cites it directly · 4 of its ownK211135 Enlight 2100Timpel S.A. · 2022
- Descendant · 2 generations on · 2 of its ownK222897 Enlight 2100Timpel S.A. · 2023
- Descendant · 3 generations on · 0 of its ownK250464 Enlight 2100 (TPL-E2103-0)Timpel S.A. · 2025
- Descendant · 3 generations on · 0 of its ownK243765 LuMon (TM) SystemSentec AG · 2025
- Descendant · 2 generations on · 0 of its ownK222466 AirTomBilab · 2023
Most influential descendants
Showing 5 of 5 · See all- K211135Enlight 2100Timpel S.A. · 2022 · cites it directly4descendants
- K222897Enlight 2100Timpel S.A. · 2023 · 2 generations on2descendants
- K250464Enlight 2100 (TPL-E2103-0)Timpel S.A. · 2025 · 3 generations on0descendants
- K243765LuMon (TM) SystemSentec AG · 2025 · 3 generations on0descendants
- K222466AirTomBilab · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN170072 | Enlight 1810 | Timpel, Inc. | 2018 | — |
| +1 | K211135 | Enlight 2100 | Timpel S.A. | 2022 | — |
| +2 | K222897 | Enlight 2100 | Timpel S.A. | 2023 | — |
| +3 | K250464 | Enlight 2100 (TPL-E2103-0) | Timpel S.A. | 2025 | — |
| +3 | K243765 | LuMon (TM) System | Sentec AG | 2025 | — |
| +2 | K222466 | AirTom | Bilab | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 2 | 0 |
Sources: FDA De Novo 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 QEB? 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 QEB device
- #1 K222897 Enlight 2100score 13.4 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211135 | Enlight 2100 | 2022 | 4 |
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, K211135 (Timpel S.A., 2022) has gone furthest, with 4 descendants of its own.
How does its category compare?
All QEB devicesQEB Ventilatory Electrical Impedance Tomograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · QEB
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QEB
Too few QEB 510(k)s in any year since 2007 to give a median.
Recalls per year · QEB
No recall names QEB since 2007.
Adverse event reports per year · QEB
No MAUDE report names QEB since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
ENLIGHT 1810 is a non-invasive, non-radiation medical device that provides information of local impedance variation within a cross-section of a patient’s thorax. This information is presented to the clinician user as an adjunctive tool to other clinical information in order to support the user’s assessment of variations in regional air content within a cross section of a patient’s lungs.
It is intended for mechanically ventilated adult patients in a hospital setting, whose thorax perimeter is within the range of 78-122 cm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN170072 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN170072: Enlight 1810.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN170072
Report an extraction error
Are you the manufacturer?
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