510(k) · Cleared
ClearedBreas HA50 Humidifier, Model HA50
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vital Signs, Inc. · BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Cleared on Mar 7, 2001 after a 209-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 of the 28 devices in its family, counting itself, have a Class I recall. 27 later devices descend from it.
- Decided
- Mar 7, 2001
- Review
- 209 days
- Class
- Class II
- Product code
- BTT
- Recalls
- None
- Predicates
- 0
27 later devices descend from it, 2 citing it directly. 5 of the 28 devices in this family, counting this one, have a Class I recall.
- This deviceK002454 Breas HA50 Humidifier, Model HA50Vital Signs, Inc. · 2001
- Descendant · cites it directly · 25 of its ownK053607 Breas Vivo 40 SystemBreas Medical AB · 2006
- Descendant · 2 generations on · 24 of its ownK071702 Breas Vivo Bilevel System, Model Vivo 40Breas Medical AB · 2008
- Descendant · 3 generations on · 23 of its ownK090113 Breas Vivo 40 SystemBreas Medical AB · 2009
- Descendant · 4 generations on · 20 of its ownK103167 Stellar 150Resmed Germany, Inc. · 2011
- Descendant · 5 generations on · 8 of its ownK113053 Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · Recalled (Class I)
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 27 · See all- K053607Breas Vivo 40 SystemBreas Medical AB · 2006 · cites it directly25descendants
- K071702Breas Vivo Bilevel System, Model Vivo 40Breas Medical AB · 2008 · 2 generations on24descendants
- K090113Breas Vivo 40 SystemBreas Medical AB · 2009 · 3 generations on23descendants
- K103167Stellar 150Resmed Germany, Inc. · 2011 · 4 generations on20descendants
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 5 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002454 | Breas HA50 Humidifier, Model HA50 | Vital Signs, Inc. | 2001 | — |
| +1 | K053607 | Breas Vivo 40 System | Breas Medical AB | 2006 | — |
| +2 | K071702 | Breas Vivo Bilevel System, Model Vivo 40 | Breas Medical AB | 2008 | — |
| +3 | K090113 | Breas Vivo 40 System | Breas Medical AB | 2009 | — |
| +4 | K103167 | Stellar 150 | Resmed Germany, Inc. | 2011 | — |
| +5 | K113053 | Bipap a 30 Ventilatory Support System | Respironics, Inc. | 2012 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 2 |
| 2013 | 2 | 1 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 1 |
| 2021 | 1 | 1 |
| 2022 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
5 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 BTT device
- #1 K222197 F&P Optiflow Junior 2/2+ Nasal Cannula…score 16.8 · 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (27)
See all 272 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (5 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.
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 15 Class I recalls
- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 6 generations on · ◆ in the 2012 descendants bar of FIG. 13 Class I recalls
- K122715Stellar 150Resmed Germany, Inc. · 2013 · 6 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K181166Trilogy EvoRespironics, Inc. · 2019 · 7 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 8 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K053607 (Breas Medical AB, 2006) has gone furthest, with 25 descendants of its own.
How does its category compare?
All BTT devicesBTT Humidifier, Respiratory Gas, (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BTT
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTT
104in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTT
1in 2025
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · BTT
1,743in 2025
MAUDE reports naming product code BTT, 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 | 6 | 73 | 1 | 365 |
| 2008 | 4 | 199 | 1 | 456 |
| 2009 | 1 | — | 0 | 558 |
| 2010 | 4 | 113 | 2 | 562 |
| 2011 | 3 | 116 | 1 | 665 |
| 2012 | 2 | — | 0 | 583 |
| 2013 | 6 | 171 | 0 | 718 |
| 2014 | 7 | 231 | 5 (4) | 718 |
| 2015 | 1 | — | 0 | 670 |
| 2016 | 3 | 157 | 0 | 1,094 |
| 2017 | 3 | 303 | 0 | 1,007 |
| 2018 | 2 | — | 0 | 918 |
| 2019 | 1 | — | 0 | 894 |
| 2020 | 2 | — | 0 | 1,188 |
| 2021 | 2 | — | 0 | 1,510 |
| 2022 | 3 | 290 | 0 | 749 |
| 2023 | 7 | 258 | 0 | 716 |
| 2024 | 7 | 219 | 0 | 501 |
| 2025 | 4 | 104 | 1 | 1,743 |
| 2026 | 4 | 184 | 1 | — |
https://510kreport.com/device/K002454 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002454: Breas HA50 Humidifier, Model HA50.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002454
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026