510(k) · Cleared
ClearedBreathe Technologies LIFE2000 Ventilation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Breathe Technologies · CBK Ventilator, Continuous, Facility Use
Cleared on Jun 12, 2015 as substantially equivalent to K060647 (Pulmonetic Systems, Inc., 2006) after a 330-day review. Its family tree reaches back 7 generations to 1991. 4 of the 39 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Jun 12, 2015
- Review
- 330 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K902859 (1991). 37 ancestors in all, the oldest K895541 (1990). 1 later device descends from it, 1 citing it directly. 4 of the 39 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 6 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 5 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 4 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 3 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 2 generations backK022674 Bird Avea VentilatorBird Products Corp. · 2002 · Recalled
- 1 generation backK060647 LTV 1200 VentilatorPulmonetic Systems, Inc. · 2006
- This deviceK141943 Breathe Technologies LIFE2000 Ventilation SystemBreathe Technologies · 2015
- Descendant · cites it directly · 0 of its ownK170037 Breathe Technologies Life2000™ Ventilation SystemBreathe Technologies · 2017 · Recalled (Class I)
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K170037Breathe Technologies Life2000™ Ventilation SystemBreathe Technologies · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −6 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −5 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −4 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −3 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −2 | K022674 | Bird Avea Ventilator | Bird Products Corp. | 2002 | 5 |
| −1 | K060647 | LTV 1200 Ventilator | Pulmonetic Systems, Inc. | 2006 | — |
| 0 (this device) | K141943 | Breathe Technologies LIFE2000 Ventilation System | Breathe Technologies | 2015 | — |
| +1 | K170037 | Breathe Technologies Life2000™ Ventilation System | Breathe Technologies | 2017 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 5 | 1 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 1 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 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.
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 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? (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 |
|---|---|---|---|
| * | K060647 | LTV 1200 VentilatorSummary page 4…e Device: LTV-1200 Predicate Device Manufacturer: Pulmonetic Systems, Inc. Predicate Device Premarket Notification # K060647 Predicate Device Common Name: Mechanical Ventilator Predicate Device Classification & Name: 21 CFR 868.… | 2006 |
| † | K103345 | Breathe Technologies Ventilator and Accessories (BT-V2S) | 2011 |
| † | K050359 | Ultra Mirage II Mask | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170037 | Breathe Technologies Life2000™ Ventilation System Class I | 2017 | 0 |
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.
- K013642AVEABird Products Corp. · 2002 · 3 generations back · ◆ on the line of descent in FIG. 113 Class I recalls
- K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · 4 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K170037Breathe Technologies Life2000™ Ventilation SystemBreathe Technologies · 2017 · Cites it directly · ◆ in the 2017 descendants bar of FIG. 112 Class I recalls
What does this lineage say?
- The line of descent spans 24 years and passes through 6 companies; a new generation was cleared every 2.7 years on median.
- 12 of the 37 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K170037 (Breathe Technologies, 2017) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K060647.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Breathe Technologies Life2000 Ventilation System is intended to provide continuous or intermittent ventilatory
support for the care of individuals who require mechanical ventilation.
The ventilator is intended for use by qualified, trained personnel under the direction of a physician.
Specifically, the ventilator is applicable for adult patients who require the following types of ventilatory support:
- Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask).
- Assist/Control mode of ventilation.
The ventilator is suitable for use in home and institutional settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141943 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141943: Breathe Technologies LIFE2000 Ventilation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141943
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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