510(k) · Cleared
ClearedEnlight 2100 (TPL-E2103-0)
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 Sep 10, 2025 as substantially equivalent to K222897 (Timpel S.A., 2023) after a 204-day review. Its family tree reaches back 10 generations to 1991. 4 of the 45 devices in its family, counting itself, have a Class I recall.
- Decided
- Sep 10, 2025
- Review
- 204 days
- Class
- Class II
- Product code
- QEB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K902859 (1991). 44 ancestors in all, the oldest K900696 (1990). No later device cites it as a predicate yet. 4 of the 45 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 6 generations between
- 3 generations backK053388 Model 840 Ventilator with Proportional Assist Ventilation Plus…Puritan Bennett Corp. · 2006 · Recalled (Class I)
- 2 generations backK103578 Philips NM3 Respiratory Monitor with VentassistRespironics Novametrix, LLC · 2011
- 1 generation backK222897 Enlight 2100Timpel S.A. · 2023
- This deviceK250464 Enlight 2100 (TPL-E2103-0)Timpel S.A. · 2025
Show all 10 generations
- Root · 10 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 9 generations backK961687 EVITA 4Drager, Inc. · 1996
- 8 generations backK970460 Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · Recalled (Class I)
- 7 generations backK984535 Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · Recalled (Class I)
- 6 generations backK022679 RaphaelHamilton Medical AG · 2003 · Recalled
- 5 generations backK040574 Galileo GoldHamilton Medical, Inc. · 2004
- 4 generations backK051263 Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa · 2005 · Recalled
- 3 generations backK053388 Model 840 Ventilator with Proportional Assist Ventilation Plus…Puritan Bennett Corp. · 2006 · Recalled (Class I)
- 2 generations backK103578 Philips NM3 Respiratory Monitor with VentassistRespironics Novametrix, LLC · 2011
- 1 generation backK222897 Enlight 2100Timpel S.A. · 2023
- This deviceK250464 Enlight 2100 (TPL-E2103-0)Timpel S.A. · 2025
Class I recalls in this family
- K053388 Model 840 Ventilator with Proportional Assist…3 generations back · 2006
- K001646 Puritan-Bennett 840 Ventilator System with…5 generations back · 2000
- K984535 Puritan-Bennett 840 Ventilatory System with…5 generations back · 1998
- K970460 Nellcor Puritan Bennett, 840 Ventilator System…6 generations back · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −9 | K961687 | EVITA 4 | Drager, Inc. | 1996 | — |
| −8 | K970460 | Nellcor Puritan Bennett, 840 Ventilator System (Model 840) | Puritan Bennett Corp. | 1998 | Class I |
| −7 | K984535 | Puritan-Bennett 840 Ventilatory System with Bilevel Option | Puritan Bennett Corp. | 1998 | Class I |
| −6 | K022679 | Raphael | Hamilton Medical AG | 2003 | 3 |
| −5 | K040574 | Galileo Gold | Hamilton Medical, Inc. | 2004 | — |
| −4 | K051263 | Evitaxl with Option Smartcare | Drager Medical AG & Co. Kgaa | 2005 | 1 |
| −3 | K053388 | Model 840 Ventilator with Proportional Assist Ventilation Plus Software Option | Puritan Bennett Corp. | 2006 | Class I |
| −2 | K103578 | Philips NM3 Respiratory Monitor with Ventassist | Respironics Novametrix, LLC | 2011 | — |
| −1 | K222897 | Enlight 2100 | Timpel S.A. | 2023 | — |
| 0 (this device) | K250464 | Enlight 2100 (TPL-E2103-0) | Timpel S.A. | 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 |
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 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 |
|---|---|---|---|
| * | K222897 | Enlight 2100Summary page 5…Ventilatory electrical impedance tomograph Product code: QEB Predicate: ENLIGHT 2100 - K222897 Regulation Number: 868.1505 Regulation Name: Ventilatory electrical impedance t… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · 5 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K984535Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · 5 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 · 6 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 34 years and passes through 8 companies; a new generation was cleared every 2.5 years on median.
- 17 of the 44 ancestors have a recall of any class; 4 have a Class I recall.
- 1 other device also cites its predicate K222897.
How does its category compare?
All QEB devicesQEB Ventilatory Electrical Impedance Tomograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 patients, from adults to infants, older than 29 days, 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/K250464 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250464: Enlight 2100 (TPL-E2103-0).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250464
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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