510(k) · Cleared
Recalled · Class II · 2015Aquapak 020 Humidifier Adapter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respiratory Care, Inc. · BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Cleared on Dec 16, 1983 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled 30 times.
- Decided
- Dec 16, 1983
- Review
- 30 days
- Class
- Class II
- Product code
- BTT
- Recalls
- 30
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK833974 Aquapak 020 Humidifier AdapterRespiratory Care, Inc. · 1983
- Descendant · cites it directly · 0 of its ownK141353 Hudson Rci Aquapak Humidifier AdaptorTeleflexmedical, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K141353Hudson Rci Aquapak Humidifier AdaptorTeleflexmedical, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K833974 | Aquapak 020 Humidifier Adapter | Respiratory Care, Inc. | 1983 | — |
| +1 | K141353 | Hudson Rci Aquapak Humidifier Adaptor | Teleflexmedical, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 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.
Planning a device in BTT? 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141353 | Hudson Rci Aquapak Humidifier Adaptor | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 14, 2015 | Class II | Z-1101-2015 | Material/Component Contamination | The packages may contain foreign material (black particles). |
| Jan 14, 2015 | Class II | Z-1102-2015 | Material/Component Contamination | The packages may contain foreign material (black particles). |
| Jan 14, 2015 | Class II | Z-1108-2015 | Material/Component Contamination | The packages may contain foreign material (black particles). |
| Jan 14, 2015 | Class II | Z-1104-2015 | Material/Component Contamination | The packages may contain foreign material (black particles). |
| Jan 14, 2015 | Class II | Z-1096-2015 | Material/Component Contamination | The packages may contain foreign material (black particles). |
| Jan 14, 2015 | Class II | Z-1107-2015 | Material/Component Contamination | The packages may contain foreign material (black particles). |
| Jan 14, 2015 | Class II | Z-1098-2015 | Material/Component Contamination | The packages may contain foreign material (black particles). |
| Jan 14, 2015 | Class II | Z-1095-2015 | Material/Component Contamination | The packages may contain foreign material (black particles). |
| Jan 14, 2015 | Class II | Z-1105-2015 | Material/Component Contamination | The packages may contain foreign material (black particles). |
| Jan 14, 2015 | Class II | Z-1097-2015 | Material/Component Contamination | The packages may contain foreign material (black particles). |
| Jan 14, 2015 | Class II | Z-1109-2015 | Material/Component Contamination | The packages may contain foreign material (black particles). |
| Jan 14, 2015 | Class II | Z-1106-2015 | Material/Component Contamination | The packages may contain foreign material (black particles). |
| Jan 14, 2015 | Class II | Z-1100-2015 | Material/Component Contamination | The packages may contain foreign material (black particles). |
| Jan 14, 2015 | Class II | Z-1099-2015 | Material/Component Contamination | The packages may contain foreign material (black particles). |
| Jan 14, 2015 | Class II | Z-1103-2015 | Material/Component Contamination | The packages may contain foreign material (black particles). |
| Jun 5, 2014 | Class II | Z-2014-2014 | Packaging change control | The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. |
| Jun 5, 2014 | Class II | Z-2016-2014 | Packaging change control | The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. |
| Jun 5, 2014 | Class II | Z-2005-2014 | Packaging change control | The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. |
| Jun 5, 2014 | Class II | Z-2011-2014 | Packaging change control | The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. |
| Jun 5, 2014 | Class II | Z-2008-2014 | Packaging change control | The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. |
| Jun 5, 2014 | Class II | Z-2004-2014 | Packaging change control | The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. |
| Jun 5, 2014 | Class II | Z-2010-2014 | Packaging change control | The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. |
| Jun 5, 2014 | Class II | Z-2017-2014 | Packaging change control | The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. |
| Jun 5, 2014 | Class II | Z-2007-2014 | Packaging change control | The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. |
| Jun 5, 2014 | Class II | Z-2015-2014 | Packaging change control | The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. |
| Jun 5, 2014 | Class II | Z-2009-2014 | Packaging change control | The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. |
| Jun 5, 2014 | Class II | Z-2006-2014 | Packaging change control | The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. |
| Jun 5, 2014 | Class II | Z-2003-2014 | Packaging change control | The seals of the respiratory gas humidifier adaptor packaging may be creased which may potentially affect packaging integrity. |
| Jun 5, 2014 | Class II | Z-2012-2014 | Packaging change control | The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. |
| Jun 5, 2014 | Class II | Z-2013-2014 | Packaging change control | The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. |
The 5 latest of 30 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K141353 (Teleflexmedical, Inc., 2014) has gone furthest, with 0 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/K833974 · printed Nov 4, 2026
Cite this page
510(k) Report. “K833974: Aquapak 020 Humidifier Adapter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K833974
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026