# K981744: Combination Toa with Nasal Mask Holder and Universal Nasal Mask Holder

- Pathway: 510(k) (Traditional)
- Applicant: W. Keith Thornton, D.D.S.
- Decided: Oct 14, 1998 after 149 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 K882303 (1989). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972061: TOA, W. Keith Thornton, D.D.S. (1997) Summary page 1.
- (no number) Respironics, Inc. - Standard Head Gear for Nasal Mask: named in the summary without a submission number

## Indications for use
The intended use for the Nasal Mask Oral Appliance Holder is that is may be used with or without the complete Oral Appliance approved for Snoring and OSA to serve as an accessory to hold a Nasal Mask on a patient’s face. The designed attachment can be fitted to hold the nasal mask in place via an oral appliance secured by the upper teeth of the patient. The accessory will have the same indications for use as those of the equipment to which it is an accessory.

Source page: https://510kreport.com/device/K981744
Methodology: https://510kreport.com/methodology