510(k) · Cleared
Recalled · Class I · 2025Breathe 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 Aug 11, 2017 as substantially equivalent to K141943 (Breathe Technologies, 2015) and 1 other predicate after a 219-day review. Its family tree reaches back 8 generations to 1991. 4 of the 43 devices in its family, counting itself, have a Class I recall. It has been recalled 13 times, including 12 Class I recalls.
- Decided
- Aug 11, 2017
- Review
- 219 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 13 (12 Class I)
- Predicates
- 2
Its longest line of descent runs back 8 generations to K902859 (1991). 42 ancestors in all, the oldest K895541 (1990). No later device cites it as a predicate yet. 4 of the 43 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 7 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 6 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 5 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 4 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 3 generations backK022674 Bird Avea VentilatorBird Products Corp. · 2002 · Recalled
- 2 generations backK060647 LTV 1200 VentilatorPulmonetic Systems, Inc. · 2006
- 1 generation backK141943 Breathe Technologies LIFE2000 Ventilation SystemBreathe Technologies · 2015
- This deviceK170037 Breathe Technologies Life2000™ Ventilation SystemBreathe Technologies · 2017
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −7 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −6 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −5 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −4 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −3 | K022674 | Bird Avea Ventilator | Bird Products Corp. | 2002 | 5 |
| −2 | K060647 | LTV 1200 Ventilator | Pulmonetic Systems, Inc. | 2006 | — |
| −1 | K141943 | Breathe Technologies LIFE2000 Ventilation System | Breathe Technologies | 2015 | — |
| 0 (this device) | K170037 | Breathe Technologies Life2000™ Ventilation System | Breathe Technologies | 2017 | — |
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 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 4 | 1 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 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 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 |
|---|---|---|---|
| * | K141943 | Breathe Technologies LIFE2000 Ventilation SystemSummary page 4…Life2000 Ventilation System Predicate Device Manufacturer: Breathe Technologies, Inc. Predicate Device Premarket Notification # K141943 Predicate Device Common Name: Continuous Ventilator Predicate Device Classification & Name: 21 CFR 868.5895… | 2015 |
| * | K062019 | Respcare Hybrid NE Face Mask, Model TBD,; Disposable, Model TBDSummary page 5…dicate Device: Hybrid NE Mask Predicate Device Manufacturer: RespCare, Inc. Predicate Device Premarket Notification # K062019 Predicate Device Common Name: Face Mask Accessory to Continuous… | 2006 |
| † | K023354 | Compressor Mini, 115 V, Model 64 81 779 EH81E | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 7, 2025 | Class I | Z-1725-2025 | Software in the Use Environment | A cybersecurity vulnerability was discovered through internal testing. |
| Apr 7, 2025 | Class I | Z-1726-2025 | Software in the Use Environment | A cybersecurity vulnerability was discovered through internal testing. |
| Dec 20, 2024 | Class I | Z-0886-2025 | Process control | There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable. |
| Dec 20, 2024 | Class I | Z-0884-2025 | Process control | There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable. |
| Dec 20, 2024 | Class I | Z-0885-2025 | Process control | There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable. |
| Dec 20, 2024 | Class I | Z-0887-2025 | Process control | There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable. |
| Sep 12, 2024 | Class I | Z-0046-2025 | Software Design Change | The Life2000 ventilator may fail to initiate the Low Gas Pressure alarm if the pressure gas source (Life2000 compressor, oxygen cylinder or wall source) is not supplied to the ventilator before initiating therapy. |
| May 29, 2024 | Class I | Z-2140-2024 | Under Investigation by firm | Potential for certain Life2000 ventilator systems to either fail to charge or have intermittent charging behavior due to damage to the battery charger dongle. Damage of the battery charger dongle prevents the ventilator's internal battery… |
| Jan 25, 2023 | Class I | Z-1142-2023 | Under Investigation by firm | There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator. |
| Jan 25, 2023 | Class I | Z-1141-2023 | Under Investigation by firm | There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator. |
| Jan 25, 2023 | Class I | Z-1140-2023 | Under Investigation by firm | There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator. |
| Jan 25, 2023 | Class I | Z-1139-2023 | Under Investigation by firm | There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator. |
| Nov 12, 2020 | Class II | Z-0484-2021 | Process control | Under certain conditions, there is a risk for fire. |
The 5 latest of 13 recalls; the web page lists all.
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 · 4 generations back · ◆ on the line of descent in FIG. 113 Class I recalls
- K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · 5 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 · 5 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 26 years and passes through 6 companies; a new generation was cleared every 2.7 years on median.
- 12 of the 42 ancestors have a recall of any class; 3 have a Class I recall.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Life2000 Ventilation System consists of the Life2000 Ventilator and the Life2000 Compressor. The System is intended for use by qualified, trained personnel under the direction of a physician. Specifically, the System is applicable for adult patients who require the…
Read the full statement (107 words)
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 Life2000 Ventilation System consists of the Life2000 Ventilator and the Life2000 Compressor.
The System is intended for use by qualified, trained personnel under the direction of a physician. Specifically, the System 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 System is suitable for use in home and institutional settings and is not intended for ambulance or air transportation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170037 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170037: 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/K170037
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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