# K121692: Minime 2 Nasal Mask

- Pathway: 510(k) (Traditional)
- Applicant: Sleepnet Corporation
- Decided: Nov 5, 2012 after 151 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: 4 generations back to K945938 (1996). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090935: Minime Pediatric Mask, Sleepnet Corporation (2009) Summary page 1.
- K060105: Vpap Iii ST-a/Kidsta Mask System, Resmed, Ltd. (2006) Summary page 1.

## Indications for use
The MiniMe 2 Nasal mask is intended to provide a patient interface for application of positive pressure therapy. The mask is to be used as an accessory to CPAP or Bi-level positive pressure systems. It is intended for patients >2 years old and <12 years old. The mask is designed and labeled for different durations of use: * Single use, disposable (hospital or institutional settings) * Single patient, multi-use (home setting) * Single patient, short-term use up to 7 days (hospital or institutional settings)

Source page: https://510kreport.com/device/K121692
Methodology: https://510kreport.com/methodology