# K833974: Aquapak 020 Humidifier Adapter

- Pathway: 510(k) (Traditional)
- Applicant: Respiratory Care, Inc.
- Decided: Dec 16, 1983 after 30 days
- Product code: BTT (Humidifier, Respiratory Gas, (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5450
- Recalls of this device: 30 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K141353: Hudson Rci Aquapak Humidifier Adaptor (2014), 0 descendants of its own

## Recalls of this device
- Jan 14, 2015 · Class II · Z-1101-2015: The packages may contain foreign material (black particles).
- Jan 14, 2015 · Class II · Z-1102-2015: The packages may contain foreign material (black particles).
- Jan 14, 2015 · Class II · Z-1108-2015: The packages may contain foreign material (black particles).
- Jan 14, 2015 · Class II · Z-1104-2015: The packages may contain foreign material (black particles).
- Jan 14, 2015 · Class II · Z-1096-2015: The packages may contain foreign material (black particles).
- Jan 14, 2015 · Class II · Z-1107-2015: The packages may contain foreign material (black particles).
- Jan 14, 2015 · Class II · Z-1098-2015: The packages may contain foreign material (black particles).
- Jan 14, 2015 · Class II · Z-1095-2015: The packages may contain foreign material (black particles).
- Jan 14, 2015 · Class II · Z-1105-2015: The packages may contain foreign material (black particles).
- Jan 14, 2015 · Class II · Z-1097-2015: The packages may contain foreign material (black particles).
- Jan 14, 2015 · Class II · Z-1109-2015: The packages may contain foreign material (black particles).
- Jan 14, 2015 · Class II · Z-1106-2015: The packages may contain foreign material (black particles).
- Jan 14, 2015 · Class II · Z-1100-2015: The packages may contain foreign material (black particles).
- Jan 14, 2015 · Class II · Z-1099-2015: The packages may contain foreign material (black particles).
- Jan 14, 2015 · Class II · Z-1103-2015: The packages may contain foreign material (black particles).
- Jun 5, 2014 · Class II · Z-2014-2014: The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.
- Jun 5, 2014 · Class II · Z-2016-2014: The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.
- Jun 5, 2014 · Class II · Z-2005-2014: The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.
- Jun 5, 2014 · Class II · Z-2011-2014: The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.
- Jun 5, 2014 · Class II · Z-2008-2014: The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.
- Jun 5, 2014 · Class II · Z-2004-2014: The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.
- Jun 5, 2014 · Class II · Z-2010-2014: The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.
- Jun 5, 2014 · Class II · Z-2017-2014: The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.
- Jun 5, 2014 · Class II · Z-2007-2014: The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.
- Jun 5, 2014 · Class II · Z-2015-2014: The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.
- Jun 5, 2014 · Class II · Z-2009-2014: The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.
- Jun 5, 2014 · Class II · Z-2006-2014: The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.
- Jun 5, 2014 · Class II · Z-2003-2014: 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: The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.
- Jun 5, 2014 · Class II · Z-2013-2014: The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.

Source page: https://510kreport.com/device/K833974
Methodology: https://510kreport.com/methodology