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 Mar 7, 2023 as substantially equivalent to K211135 (Timpel S.A., 2022) and 1 other predicate after a 165-day review. Its family tree reaches back 9 generations to 1991. 4 of the 46 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.
- Decided
- Mar 7, 2023
- Review
- 165 days
- Class
- Class II
- Product code
- QEB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K902859 (1991). 43 ancestors in all, the oldest K900696 (1990). 2 later devices descend from it, 2 citing it directly. 4 of the 46 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 5 generations between
- 3 generations backK051263 Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa · 2005 · Recalled
- 2 generations backK053388 Model 840 Ventilator with Proportional Assist Ventilation Plus…Puritan Bennett Corp. · 2006 · Recalled (Class I)
- 1 generation backK103578 Philips NM3 Respiratory Monitor with VentassistRespironics Novametrix, LLC · 2011
- This deviceK222897 Enlight 2100Timpel S.A. · 2023
- Descendant · cites it directly · 0 of its ownK250464 Enlight 2100 (TPL-E2103-0)Timpel S.A. · 2025
- Descendant · cites it directly · 0 of its ownK243765 LuMon (TM) SystemSentec AG · 2025
Show all 9 generations
- Root · 9 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 8 generations backK961687 EVITA 4Drager, Inc. · 1996
- 7 generations backK970460 Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · Recalled (Class I)
- 6 generations backK984535 Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · Recalled (Class I)
- 5 generations backK022679 RaphaelHamilton Medical AG · 2003 · Recalled
- 4 generations backK040574 Galileo GoldHamilton Medical, Inc. · 2004
- 3 generations backK051263 Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa · 2005 · Recalled
- 2 generations backK053388 Model 840 Ventilator with Proportional Assist Ventilation Plus…Puritan Bennett Corp. · 2006 · Recalled (Class I)
- 1 generation backK103578 Philips NM3 Respiratory Monitor with VentassistRespironics Novametrix, LLC · 2011
- This deviceK222897 Enlight 2100Timpel S.A. · 2023
Class I recalls in this family
- K053388 Model 840 Ventilator with Proportional Assist…2 generations back · 2006
- K001646 Puritan-Bennett 840 Ventilator System with…4 generations back · 2000
- K984535 Puritan-Bennett 840 Ventilatory System with…4 generations back · 1998
- K970460 Nellcor Puritan Bennett, 840 Ventilator System…5 generations back · 1998
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 |
|---|---|---|---|---|---|
| −9 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −8 | K961687 | EVITA 4 | Drager, Inc. | 1996 | — |
| −7 | K970460 | Nellcor Puritan Bennett, 840 Ventilator System (Model 840) | Puritan Bennett Corp. | 1998 | Class I |
| −6 | K984535 | Puritan-Bennett 840 Ventilatory System with Bilevel Option | Puritan Bennett Corp. | 1998 | Class I |
| −5 | K022679 | Raphael | Hamilton Medical AG | 2003 | 3 |
| −4 | K040574 | Galileo Gold | Hamilton Medical, Inc. | 2004 | — |
| −3 | K051263 | Evitaxl with Option Smartcare | Drager Medical AG & Co. Kgaa | 2005 | 1 |
| −2 | K053388 | Model 840 Ventilator with Proportional Assist Ventilation Plus Software Option | Puritan Bennett Corp. | 2006 | Class I |
| −1 | K103578 | Philips NM3 Respiratory Monitor with Ventassist | Respironics Novametrix, LLC | 2011 | — |
| 0 (this device) | K222897 | Enlight 2100 | Timpel S.A. | 2023 | — |
| +1 | K250464 | Enlight 2100 (TPL-E2103-0) | Timpel S.A. | 2025 | — |
| +1 | K243765 | LuMon (TM) System | Sentec AG | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 4 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 1 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
4 devices in this family have a Class I recall. 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 K250464 Enlight 2100 (TPL-E2103-0)score 12.7 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K211135 | Enlight 2100Summary page 4…868.1850 Regulation Name: Spirometer, Monitoring (W/Wo Alarm) Primary Predicate: Primary Predicate - ENLIGHT 2100 - K211135 Regulation Number: 868.1505 Regulation Name: Ventilatory electrical impedance tom… | 2022 |
| * | K103578 | Philips NM3 Respiratory Monitor with VentassistSummary page 4…al impedance tomograph Product code: QEB Secondary Predicate: Philips NM3 Respiratory Profile Monitor with VentAssist – K103578 Regulation Number: 868.1850 Regulation Name: Spirometer, Monitoring (W/Wo Alarm)… | 2011 |
| † | K963380 | CO 2 Smo Plus | 1997 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K053388Model 840 Ventilator with Proportional Assist Ventilation Plus Software OptionPuritan Bennett Corp. · 2006 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · 4 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K984535Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 32 years and passes through 8 companies; a new generation was cleared every 1.4 years on median.
- 17 of the 43 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K250464 (Timpel S.A., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K211135.
How does its category compare?
All QEB devicesQEB Ventilatory Electrical Impedance Tomograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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, radiation free medical device that provides information from impedance variation from 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 thorax.
ENLIGHT 2100 also provides respiratory parameters based on spirometric monitoring.
It is intended for mechanically ventilated adult and pediatric patients in a hospital setting, whose thorax perimeter is within the range of 37.5 – 134 cm.
ENLIGHT 2100 does not measure regional ventilation of the lungs
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222897 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222897: 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/K222897
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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