510(k) · Cleared
Recalled · Class I · 2024Puritan Bennett Legendair XL2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nellcor Puritan Bennett · CBK Ventilator, Continuous, Facility Use
Cleared on Dec 13, 2007 as substantially equivalent to K003770 (Bird Products Corp., 2000) and 1 other predicate after a 255-day review. Its family tree reaches back 5 generations to 1991. 2 of the 24 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Dec 13, 2007
- Review
- 255 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 1 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 5 generations to K902859 (1991). 15 ancestors in all. 8 later devices descend from it, 3 citing it directly. 2 of the 24 devices in this family, counting this one, have 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 deviceK070899 Puritan Bennett Legendair XL2Nellcor Puritan Bennett · 2007
- Descendant · cites it directly · 5 of its ownK082982 Breathe Technologies Ventilator and AccessoriesBreathe Technologies, Inc. · 2009
- Descendant · 2 generations on · 4 of its ownK100528 Breathe Technologies Ventilator and Accessories BT-V2SBreathe Technologies, Inc. · 2010
- Descendant · 3 generations on · 3 of its ownK102525 Breathe Technologies Ventilator and Accessories (BT-V2S)Breathe Technologies, Inc. · 2010
- Descendant · 4 generations on · 2 of its ownK103345 Breathe Technologies Ventilator and Accessories (BT-V2S)Breathe Technologies, Inc. · 2011
- Descendant · 5 generations on · 1 of its ownK131562 Breathe Niov Ventilation SystemBreathe Technologies · 2014
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K023366 Datex-Ohmeda 7900 Ventilator Enhancements3 generations back · 2003
Most influential descendants
Showing 5 of 8 · See all- K082982Breathe Technologies Ventilator and AccessoriesBreathe Technologies, Inc. · 2009 · cites it directly5descendants
- K100528Breathe Technologies Ventilator and Accessories BT-V2SBreathe Technologies, Inc. · 2010 · 2 generations on4descendants
- K102525Breathe Technologies Ventilator and Accessories (BT-V2S)Breathe Technologies, Inc. · 2010 · 3 generations on3descendants
- K103345Breathe Technologies Ventilator and Accessories (BT-V2S)Breathe Technologies, Inc. · 2011 · 4 generations on2descendants
- K131562Breathe Niov Ventilation SystemBreathe Technologies · 2014 · 5 generations on1descendant
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) | K070899 | Puritan Bennett Legendair XL2 | Nellcor Puritan Bennett | 2007 | — |
| +1 | K082982 | Breathe Technologies Ventilator and Accessories | Breathe Technologies, Inc. | 2009 | — |
| +2 | K100528 | Breathe Technologies Ventilator and Accessories BT-V2S | Breathe Technologies, Inc. | 2010 | — |
| +3 | K102525 | Breathe Technologies Ventilator and Accessories (BT-V2S) | Breathe Technologies, Inc. | 2010 | — |
| +4 | K103345 | Breathe Technologies Ventilator and Accessories (BT-V2S) | Breathe Technologies, Inc. | 2011 | — |
| +5 | K131562 | Breathe Niov Ventilation System | Breathe Technologies | 2014 | — |
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 |
| 2000 | 1 | 0 |
| 2003 | 2 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 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.
2 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 CBK device
- #1 K252663 Inbentus Versatilescore 16.0 · 17 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 |
|---|---|---|---|
| * | K003770 | Bird Tbird Legacy VentilatorSummary page 1…Continuous Ventilator Classification Name: Ventilator (CBK) per 21 CFR §868.5895 Substantially Equivalent Devices: TBird Legacy (K003770) and Pulmonetic Systems LTV 1000 (KO51767) DEVICE DESCRIPTION The LEGENDAIR® XL2 ven… | 2000 |
| * | K051767 | LTV 1000 Ventilator | 2005 |
| † | K032451 | Bird Tbird Vela Ventilator | 2004 |
What descends from it? (8)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 24, 2024 | Class I | Z-2446-2024 | Device Design | Any single affected ventilator should only be used for the 10- year labelled service life, but if longer ventilatory support is required using more than one ventilator over time, the use of these devices for more than 14 years of… |
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 16 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 5 of the 15 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K082982 (Breathe Technologies, Inc., 2009) has gone furthest, with 5 descendants of its own.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · CBK
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CBK
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CBK
14in 2024
Class I (81 since 2007) Class II/III not classified
Adverse event reports per year · CBK
13,991in 2025
MAUDE reports naming product code CBK, 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 | 11 | 142 | 17 | 1,531 |
| 2008 | 18 | 115 | 23 | 1,933 |
| 2009 | 12 | 122 | 8 | 1,766 |
| 2010 | 14 | 150 | 9 | 1,799 |
| 2011 | 13 | 192 | 12 | 1,877 |
| 2012 | 17 | 207 | 2 (1) | 5,509 |
| 2013 | 5 | 277 | 5 (2) | 7,921 |
| 2014 | 5 | 439 | 5 (4) | 7,600 |
| 2015 | 7 | 266 | 6 (4) | 11,876 |
| 2016 | 4 | 323 | 4 (1) | 16,056 |
| 2017 | 6 | 280 | 1 | 14,451 |
| 2018 | 4 | 183 | 3 (3) | 9,849 |
| 2019 | 8 | 435 | 14 (13) | 9,100 |
| 2020 | 5 | 176 | 4 | 11,096 |
| 2021 | 6 | 267 | 21 (19) | 13,322 |
| 2022 | 0 | — | 8 (4) | 15,974 |
| 2023 | 5 | 309 | 4 (3) | 24,928 |
| 2024 | 9 | 203 | 14 (14) | 20,336 |
| 2025 | 4 | 163 | 0 | 13,991 |
| 2026 | 3 | 235 | 15 (13) | — |
What is it indicated for?
The Legendair XL2 is indicated for the continuous or intermittent mechanical ventilatory support of patients weighing at least 5 kg who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients who require the following general types of ventilatory support, as prescribed by an…
Read the full statement (114 words)
The Legendair XL2 is indicated for the continuous or intermittent mechanical ventilatory support of patients weighing at least 5 kg who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients who require the following general types of ventilatory support, as prescribed by an attending physician:
• Positive Pressure ventilation
* Assist/Control, SIMV, or CPAP modes of ventilation
* Breath types including Volume, Pressure Control and Pressure Support.
The ventilator is suitable for use in institutional, home, and transport settings. It is not intended for use as an emergency transport ventilator.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070899 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070899: Puritan Bennett Legendair XL2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070899
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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