# K010402: Smooth-Flo Circuit

- Pathway: 510(k) (Special)
- Applicant: Hudson Respiratory Care, Inc.
- Decided: Mar 14, 2001 after 30 days
- Product code: BTT (Humidifier, Respiratory Gas, (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
2 of 4 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
- K061736: Comfort Flo Humidification System and Nasal Cannula (2006), 2 descendants of its own
- K131912: Conchatherm Neptune Heated Humidifier, Comfort Flo Humidification System, Conchasmart Column (2014), 1 descendant of its own
- K162242: Comfort Flo Humidification System (2017), 0 descendants of its own

Source page: https://510kreport.com/device/K010402
Methodology: https://510kreport.com/methodology