510(k) · Cleared
ClearedValence InVent Xtend™ (CVG-4101-VXA)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Convergence Medical Sciences, Ltd. · MOD Accessory To Continuous Ventilator (Respirator)
Cleared on Aug 20, 2026 as substantially equivalent to K051767 (Pulmonetic Systems, Inc., 2005) after a 265-day review. Its family tree reaches back 5 generations to 1991. 1 of the 15 devices in its family, counting itself, has a Class I recall.
- Decided
- Aug 20, 2026
- Review
- 265 days
- Class
- Class II
- Product code
- MOD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K902859 (1991). 14 ancestors in all. No later device cites it as a predicate yet. 1 of the 15 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 4 generations backK961687 EVITA 4Drager, Inc. · 1996
- 3 generations backK970165 Evita 2 DuraDrager, Inc. · 1997
- 2 generations backK041775 GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2004
- 1 generation backK051767 LTV 1000 VentilatorPulmonetic Systems, Inc. · 2005
- This deviceK253807 Valence InVent Xtend™ (CVG-4101-VXA)Convergence Medical Sciences, Ltd. · 2026
Class I recalls in this family
- K023366 Datex-Ohmeda 7900 Ventilator Enhancements3 generations back · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −4 | K961687 | EVITA 4 | Drager, Inc. | 1996 | — |
| −3 | K970165 | Evita 2 Dura | Drager, Inc. | 1997 | — |
| −2 | K041775 | GE Datex-Ohmeda Engstrom Carestation | Datex-Ohmeda, Inc. | 2004 | — |
| −1 | K051767 | LTV 1000 Ventilator | Pulmonetic Systems, Inc. | 2005 | — |
| 0 (this device) | K253807 | Valence InVent Xtend™ (CVG-4101-VXA) | Convergence Medical Sciences, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2003 | 2 | 1 |
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.
1 device in this family has 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 MOD device
- #1 K261360 EasyCare Tx 2score 14.6 · 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? (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 |
|---|---|---|---|
| * | K051767 | LTV 1000 VentilatorSummary page 7…ally Marketed Device to which Substantial Equivalence is claimed: 510(k) No.: Trade Name Company K051767 LTV 1000 Pulmonetic Systems, Inc. Summary of Subst… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 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.
- K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · 3 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 35 years and passes through 5 companies; a new generation was cleared every 5.6 years on median.
- 5 of the 14 ancestors have a recall of any class; 1 has a Class I recall.
- 5 other devices also cite its predicate K051767.
How does its category compare?
All MOD devicesMOD Accessory To Continuous Ventilator (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · MOD
3so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · MOD
125in 2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOD
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOD
1in 2022
MAUDE reports naming product code MOD, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 1 | — | 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 | 3 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 3 | 125 | 1 | — |
What is it indicated for?
Valence InVent Xtend™ is indicated for patients with pathological lung conditions or other medical conditions that
require endobronchial intubation, mechanical ventilation and isolation of one lung from the other (e.g. for unilateral chest
trauma, asymmetric ARDS).
Valence InVent Xtend™ is intended to be used with a ventilator in a pressure regulated mode (e.g. Pressure Control mode
or equivalent). Valence InVent Xtend™ is intended for patients 10 years or older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253807 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253807: Valence InVent Xtend™ (CVG-4101-VXA).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253807
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026