# K051559: Imask, Models 100, 200 and 300

- Pathway: 510(k) (Special)
- Applicant: Vital Signs Colorado, Inc.
- Decided: Jul 8, 2005 after 25 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This device is intended to be used with positive airway pressure devices operating at or above 4cmH0O for the treatment of adult obstructive sleep apnea. The mask is intended for single patient use, or multiple patient use with proper high level disinfection. The mask may be reprocessed per the high level disinfection procedure, by clinical institutions only.

Source page: https://510kreport.com/device/K051559
Methodology: https://510kreport.com/methodology