# K974453: Nasal Interface Model 7910

- Pathway: 510(k) (Traditional)
- Applicant: Healthdyne Technologies, Inc.
- Decided: Aug 4, 1998 after 252 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.
43 later devices descend from it; 2 cite it directly.
7 of 44 devices 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.

## Most influential descendants
- K053352: Comfortlite Nasal Mask (2006), 41 descendants of its own
- K082558: Comfortlite Nasal Mask (2009), 36 descendants of its own
- K102746: Mirage FX (2010), 19 descendants of its own
- K123979: Quattro Air (2013), 9 descendants of its own
- K102502: Golife Nasal Mask (2010), 9 descendants of its own

## Indications for use
The Nasal Interface is intended for use with nasal CPAP and bilevel devices for the treatment of adult patients with Obstructive Sleep Apnea. The Nasal Interface may be used in the home, hospital, nursing home, sub-acute care center or other location where nasal CPAP or bilevel therapy is applied. The Nasal Interface will facilitate nasal CPAP or bilevel therapy via a silicone seal which makes contact solely with the patient's nose on the external aspects of the nares. This device is further supported by padded protuberances, which rest on the patient's cheeks below the zygomatic processes. The device is held in place with headgear, which extends back from the nasal interface around the back and top of the patient's head.

Source page: https://510kreport.com/device/K974453
Methodology: https://510kreport.com/methodology