510(k) · Cleared
ClearedCombination Toa with Nasal Mask Holder and Universal Nasal Mask Holder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W. Keith Thornton, D.D.S. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Oct 14, 1998 as substantially equivalent to K972061 (W. Keith Thornton, D.D.S., 1997) after a 149-day review. Its family tree reaches back 3 generations to 1989.
- Decided
- Oct 14, 1998
- Review
- 149 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K882303 (1989). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 2 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
- 1 generation backK972061 TOAW. Keith Thornton, D.D.S. · 1997
- This deviceK981744 Combination Toa with Nasal Mask Holder and Universal Nasal Mask HolderW. Keith Thornton, D.D.S. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −2 | K962516 | Tap Anti-Snoring Device | Nellcor Puritan Bennett, Inc. | 1996 | — |
| −1 | K972061 | TOA | W. Keith Thornton, D.D.S. | 1997 | — |
| 0 (this device) | K981744 | Combination Toa with Nasal Mask Holder and Universal Nasal Mask Holder | W. Keith Thornton, D.D.S. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BZD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BZD device
- #1 K250624 myAirscore 15.7 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K972061 | TOASummary page 1…ornton, D.D.S. Nasal Mask Holder Nasal Mask Holder Accessory to Non-continuous Ventilator Universal Nasal Mask Holder and Combination Oral Appliance Thornton - TOA - K972061 Respironics, Inc. - Standard Head Gear for Nasal Mask - no K#. Device Description: 1. The Universal Nasal Mask Oral Appliance… | 1997 |
| * | — | Respironics, Inc. - Standard Head Gear for Nasal Mask Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- None of the 5 ancestors has a recall.
- 9 other devices also cite its predicate K972061.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BZD
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BZD
189in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZD
8in 2023
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · BZD
60,279in 2025
MAUDE reports naming product code BZD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 21 | 83 | 29 | 65 |
| 2008 | 17 | 108 | 2 | 67 |
| 2009 | 23 | 90 | 1 | 147 |
| 2010 | 12 | 122 | 0 | 143 |
| 2011 | 23 | 125 | 1 | 189 |
| 2012 | 21 | 133 | 0 | 139 |
| 2013 | 23 | 127 | 0 | 82 |
| 2014 | 14 | 172 | 0 | 86 |
| 2015 | 11 | 224 | 0 | 114 |
| 2016 | 12 | 217 | 0 | 118 |
| 2017 | 5 | 221 | 0 | 148 |
| 2018 | 5 | 280 | 0 | 101 |
| 2019 | 6 | 231 | 4 (4) | 188 |
| 2020 | 6 | 137 | 0 | 126 |
| 2021 | 6 | 192 | 0 | 6,066 |
| 2022 | 4 | 253 | 0 | 90,768 |
| 2023 | 5 | 204 | 8 (7) | 27,987 |
| 2024 | 10 | 132 | 0 | 68,262 |
| 2025 | 7 | 189 | 0 | 60,279 |
| 2026 | 10 | 214 | 2 (2) | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981744 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981744: Combination Toa with Nasal Mask Holder and Universal Nasal Mask Holder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981744
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026