# K090935: Minime Pediatric Mask

- Pathway: 510(k) (Traditional)
- Applicant: Sleepnet Corporation
- Decided: Jul 1, 2009 after 90 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K945938 (1996). 22 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073600: Comfortgel Full Face Mask, Respironics Inc., Sleep & Home Respiratory Group (2008) Summary page 1.
- K954207: Gel Mask, Respironics, Inc. (1996) Summary page 1.
- K053352: Comfortlite Nasal Mask, Respironics, Inc. (2006) Summary page 1.
- K032922: Clarissa Infant Ncpap Cannula, Airways Ltd., Inc. (2004) Summary page 1.
- K060105: Vpap Iii ST-a/Kidsta Mask System, Resmed, Ltd. (2006) Summary page 1.
- K013306: Minime Nasal Mask, Model P/N 50220, Sleepnet Corporation (2001) Summary page 2.

## Most influential descendants
- 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
- 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
- K151683: SleepWeaver Advance Pediatric Nasal CPAP Mask (2016), 0 descendants of its own
- K121692: Minime 2 Nasal Mask (2012), 0 descendants of its own

## Indications for use
The MiniMeTM Pediatric Mask is intended to provide an interface for application of CPAP or bi-level therapy. It is intended for patients > 2 years old and < 12 years old. The MiniMe Pediatric Mask is intended for single patient, multi-use in the home environment and multiple patients, multi-use in the hospital/ institutional environment.

Source page: https://510kreport.com/device/K090935
Methodology: https://510kreport.com/methodology