510(k) · Cleared
ClearedBreathe Technologies Ventilator and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Breathe Technologies, Inc. · ONZ Mechanical Ventilator
Cleared on Jul 20, 2009 as substantially equivalent to K981371 (Pulmonetic Systems, Inc., 1998) and 1 other predicate after a 287-day review. Its family tree reaches back 6 generations to 1991. 2 of the 24 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it.
- Decided
- Jul 20, 2009
- Review
- 287 days
- Class
- Class II
- Product code
- ONZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K902859 (1991). 18 ancestors in all. 5 later devices descend from it, 1 citing it directly. 2 of the 24 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 5 generations backK961687 EVITA 4Drager, Inc. · 1996
- 4 generations backK970165 Evita 2 DuraDrager, Inc. · 1997
- 3 generations backK041775 GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2004
- 2 generations backK051767 LTV 1000 VentilatorPulmonetic Systems, Inc. · 2005
- 1 generation backK070899 Puritan Bennett Legendair XL2Nellcor Puritan Bennett · 2007 · Recalled (Class I)
- This deviceK082982 Breathe Technologies Ventilator and AccessoriesBreathe Technologies, Inc. · 2009
- Descendant · cites it directly · 4 of its ownK100528 Breathe Technologies Ventilator and Accessories BT-V2SBreathe Technologies, Inc. · 2010
- Descendant · 2 generations on · 3 of its ownK102525 Breathe Technologies Ventilator and Accessories (BT-V2S)Breathe Technologies, Inc. · 2010
- Descendant · 3 generations on · 2 of its ownK103345 Breathe Technologies Ventilator and Accessories (BT-V2S)Breathe Technologies, Inc. · 2011
- Descendant · 4 generations on · 1 of its ownK131562 Breathe Niov Ventilation SystemBreathe Technologies · 2014
- Descendant · 5 generations on · 0 of its ownK152664 TAV SystemNew Aera, Inc. · 2016
Class I recalls in this family
Most influential descendants
Showing 5 of 5 · See all- K100528Breathe Technologies Ventilator and Accessories BT-V2SBreathe Technologies, Inc. · 2010 · cites it directly4descendants
- K102525Breathe Technologies Ventilator and Accessories (BT-V2S)Breathe Technologies, Inc. · 2010 · 2 generations on3descendants
- K103345Breathe Technologies Ventilator and Accessories (BT-V2S)Breathe Technologies, Inc. · 2011 · 3 generations on2descendants
- K131562Breathe Niov Ventilation SystemBreathe Technologies · 2014 · 4 generations on1descendant
- K152664TAV SystemNew Aera, Inc. · 2016 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −5 | K961687 | EVITA 4 | Drager, Inc. | 1996 | — |
| −4 | K970165 | Evita 2 Dura | Drager, Inc. | 1997 | — |
| −3 | K041775 | GE Datex-Ohmeda Engstrom Carestation | Datex-Ohmeda, Inc. | 2004 | — |
| −2 | K051767 | LTV 1000 Ventilator | Pulmonetic Systems, Inc. | 2005 | — |
| −1 | K070899 | Puritan Bennett Legendair XL2 | Nellcor Puritan Bennett | 2007 | Class I |
| 0 (this device) | K082982 | Breathe Technologies Ventilator and Accessories | Breathe Technologies, Inc. | 2009 | — |
| +1 | K100528 | Breathe Technologies Ventilator and Accessories BT-V2S | Breathe Technologies, Inc. | 2010 | — |
| +2 | K102525 | Breathe Technologies Ventilator and Accessories (BT-V2S) | Breathe Technologies, Inc. | 2010 | — |
| +3 | K103345 | Breathe Technologies Ventilator and Accessories (BT-V2S) | Breathe Technologies, Inc. | 2011 | — |
| +4 | K131562 | Breathe Niov Ventilation System | Breathe Technologies | 2014 | — |
| +5 | K152664 | TAV System | New Aera, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 2 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K981371 | LTV 1000 VentilatorSummary page 1…ity Use Predicate Device Classification: 21 CFR 868.5895 Predicate Device Classification & Code: Class II, CBK Premarket Notification Number: K98 1371 Predicate Device: Legendair XL2 Predicate Device Manufacturer: Puritan Bennett Predicate… | 1998 |
| * | K070899 | Puritan Bennett Legendair XL2Summary page 1…ity Use Predicate Device Classification: 21 CFR 868.5895 Predicate Device Classification & Code: Class II, CBK Premarket Notification Number: K070899 b. Date Summary Prepared 10 June 2009 c. Description of Device c.l. Intended Patient Populations and Medical Conditio… | 2007 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100528 | Breathe Technologies Ventilator and Accessories BT-V2S | 2010 | 4 |
Has anything in its family been recalled? (2 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.
What does this lineage say?
- The line of descent spans 18 years and passes through 6 companies; a new generation was cleared every 2.4 years on median.
- 7 of the 18 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K100528 (Breathe Technologies, Inc., 2010) has gone furthest, with 4 descendants of its own.
- 5 other devices also cite its predicate K981371.
How does its category compare?
All ONZ devicesONZ Mechanical Ventilator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · ONZ
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · ONZ
Too few ONZ 510(k)s in any year since 2007 to give a median.
Recalls per year · ONZ
No recall names ONZ since 2007.
Adverse event reports per year · ONZ
1in 2020
MAUDE reports naming product code ONZ, 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 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Breathe Technologies™ Ventilator, with accessories, is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients with a tracheostomy that are capable of spontaneously breathing a minimum tidal volume of 3.5cc/kg of predicted body weight. The device is designed for continuous applications such as patient ambulation, physical therapy, occupational therapy, respiratory therapy, and other rehabilitation efforts in an institutional environment. The device is intended for operation by trained personnel under the direction of a physician.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K082982 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082982: Breathe Technologies Ventilator and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082982
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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