# K041309: Imask TM

- Pathway: 510(k) (Traditional)
- Applicant: Vital Signs, Inc.
- Decided: Jun 30, 2004 after 44 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: 1 generation back to K993269 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993269: IQ Nasal Mask, Model P/N 50160, Sleepnet Corporation (1999) Summary page 1.

## Indications for use
This device is intended to be used with positive airway pressure devices operating at or above 4cmH20 for the treatment of adult obstructive sleep apnea.

Source page: https://510kreport.com/device/K041309
Methodology: https://510kreport.com/methodology