# K032922: Clarissa Infant Ncpap Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Airways Ltd., Inc.
- Decided: Sep 22, 2004 after 366 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K792018 (1979). 5 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K811409: Argyle Cpap Nasal Cannula, Sherwood Medical Co. (1981) Summary page 1.
- K792018: Silicone Rubber-BI Nasopharyngeal Air, Vesta, Inc. (1979) Summary page 1.
- K861280: Medicomp Cpap Nasal Cannula, Medicomp, Inc. (1986) Summary page 1.
- K871157: C.P.a.P. Nasal Cannula, Hudson Oxygen Therapy Sales Co. (1987) Summary page 1.
- K895031: Modified Infant Nasal Cannulae Assembly, Ackrad Laboratories (1989) Summary page 1.

## Most influential descendants
- K090935: Minime Pediatric Mask (2009), 5 descendants of its own
- K102224: Pixi Pediatric Mask (2010), 3 descendants of its own
- K120920: Hsiner Cpap Silicone Nasal Mask Size XS/Petite  Hsiner Nasal Pillow Mask Hsiner Infant Cpap Cannula (2012), 1 descendant of its own
- K250651: OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS (OPTIPAPPXXS); OptiPAP Junior Nasal Prongs XS (OPTIPAPPXS); OptiPAP Junior Nasal Prongs S (OPTIPAPPS); OptiPAP Junior Nasal Prongs M (OPTIPAPPM); OptiPAP Junior Nasal Prongs L (OPTIPAPPL); OptiPAP Junior Nasal Prongs XL (OPTIPAPPXL); OptiPAP Junior Nasal Mask XXS (OPTIPAPMXXS); OptiPAP Junior Nasal Mask XS (OPTIPAPMXS); OptiPAP Junior Nasal Mask S (OPTIPAPMS); OptiPAP Junior Nasal Mask M (OPTIPAPMM); OptiPAP Jun (2025), 0 descendants of its own
- K243225: Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L) (2024), 0 descendants of its own

## Indications for use
The Clarissa Infant nCPAP Cannula is intended to be used for the administration of continuous positive airway pressure (CPAP) on continuously monitored neonatal and infant patients in the hospital/institutional environment.

Source page: https://510kreport.com/device/K032922
Methodology: https://510kreport.com/methodology