510(k) · Cleared
ClearedEnlight 2100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Timpel S.A. · QEB Ventilatory Electrical Impedance Tomograph
Cleared on Jan 6, 2022 as substantially equivalent to DEN170072 (Timpel, Inc., 2018) after a 265-day review. Its family tree reaches back 1 generation to 2018. 4 later devices descend from it.
- Decided
- Jan 6, 2022
- Review
- 265 days
- Class
- Class II
- Product code
- QEB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN170072 (2018). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backDEN170072 Enlight 1810Timpel, Inc. · 2018
- This deviceK211135 Enlight 2100Timpel S.A. · 2022
- Descendant · cites it directly · 2 of its ownK222897 Enlight 2100Timpel S.A. · 2023
- Descendant · 2 generations on · 0 of its ownK250464 Enlight 2100 (TPL-E2103-0)Timpel S.A. · 2025
- Descendant · 2 generations on · 0 of its ownK243765 LuMon (TM) SystemSentec AG · 2025
- Descendant · cites it directly · 0 of its ownK222466 AirTomBilab · 2023
Most influential descendants
Showing 4 of 4 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN170072 | Enlight 1810 | Timpel, Inc. | 2018 | — |
| 0 (this device) | K211135 | Enlight 2100 | Timpel S.A. | 2022 | — |
| +1 | K222897 | Enlight 2100 | Timpel S.A. | 2023 | — |
| +2 | K250464 | Enlight 2100 (TPL-E2103-0) | Timpel S.A. | 2025 | — |
| +2 | K243765 | LuMon (TM) System | Sentec AG | 2025 | — |
| +1 | K222466 | AirTom | Bilab | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2025 | 2 | 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 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
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 |
|---|---|---|---|
| * | DEN170072 | Enlight 1810Summary page 4…Ventilatory electrical impedance tomograph Product code: QEB Predicate Device: Timpel – ENLIGHT 1810 – DEN170072 Device Description: ENLIGHT 2100 is a Ventilatory electrical impedance tomograph that uses several electrodes (usually between 1… | 2018 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K222897 (Timpel S.A., 2023) has gone furthest, with 2 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. 2022, 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 2100 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 and pediatric patients in a hospital setting, whose thorax perimeter is within the range of 37.5 - 134cm.
ENLIGHT 2100 does not measure regional ventilation of the lungs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211135 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211135: Enlight 2100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211135
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