510(k) · Cleared
ClearedRhinoguard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Davis Medical · BTR Tube, Tracheal (W/Wo Connector)
Cleared on Apr 20, 2015 as substantially equivalent to K931164 (Rusch, Inc., 1993) and 1 other predicate after a 294-day review. Its family tree reaches back 1 generation to 1993. 2 of the 3 devices in its family, counting itself, have a Class I recall.
- Decided
- Apr 20, 2015
- Review
- 294 days
- Class
- Class II
- Product code
- BTR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K931165 (1993). 2 ancestors in all. No later device cites it as a predicate yet. 2 of the 3 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK931165 Rusch Agt PVC Pref Nasal Trach Tub/Uncuf W/Mur EyeRusch, Inc. · 1993 · Recalled (Class I)
- This deviceK141747 RhinoguardDavis Medical · 2015
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931165 | Rusch Agt PVC Pref Nasal Trach Tub/Uncuf W/Mur Eye | Rusch, Inc. | 1993 | Class I |
| 0 (this device) | K141747 | Rhinoguard | Davis Medical | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 1 |
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.
2 devices in this family have a Class I recall. 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 BTR device
- #1 K251794 Tenax® Laser Resistant Endotracheal Tubescore 12.5 · 3 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 |
|---|---|---|---|
| * | K931164 | Rusch Agt PVC Preform Nasal Trach Tub/Cuf W/Mur EYSummary page 5…Class II 510(k) Number: K931164 & K931165 Device Description The Rhinoguard is a nasal endotracheal tube introducer/di… | 1993 |
| * | K931165 | Rusch Agt PVC Pref Nasal Trach Tub/Uncuf W/Mur EyeSummary page 5…Class II 510(k) Number: K931164 & K931165 Device Description The Rhinoguard is a nasal endotracheal tube introducer/dilator designe… | 1993 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K931164Rusch Agt PVC Preform Nasal Trach Tub/Cuf W/Mur EYRusch, Inc. · 1993 · Direct predicate · ◆ in the 1993 ancestors bar of FIG. 110 Class I recalls
- K931165Rusch Agt PVC Pref Nasal Trach Tub/Uncuf W/Mur EyeRusch, Inc. · 1993 · Direct predicate · ◆ on the line of descent in FIG. 17 Class I recalls
What does this lineage say?
- 2 of the 2 ancestors have a recall of any class; 2 have a Class I recall.
- 1 other device also cites its predicate K931164.
How does its category compare?
All BTR devicesBTR Tube, Tracheal (W/Wo Connector): FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · BTR
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTR
258in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTR
3in 2022
Class I (20 since 2007) Class II/III not classified
Adverse event reports per year · BTR
1,799in 2025
MAUDE reports naming product code BTR, 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 | 1 | — | 2 | 136 |
| 2008 | 7 | 61 | 0 | 169 |
| 2009 | 7 | 135 | 21 | 155 |
| 2010 | 3 | 179 | 0 | 335 |
| 2011 | 2 | — | 0 | 422 |
| 2012 | 5 | 261 | 0 | 511 |
| 2013 | 1 | — | 0 | 807 |
| 2014 | 3 | 308 | 20 (19) | 985 |
| 2015 | 3 | 262 | 0 | 1,016 |
| 2016 | 1 | — | 1 | 836 |
| 2017 | 2 | — | 0 | 812 |
| 2018 | 5 | 242 | 0 | 977 |
| 2019 | 5 | 211 | 0 | 1,379 |
| 2020 | 3 | 246 | 1 (1) | 1,070 |
| 2021 | 1 | — | 2 | 1,329 |
| 2022 | 1 | — | 3 | 1,132 |
| 2023 | 1 | — | 0 | 1,330 |
| 2024 | 1 | — | 0 | 1,678 |
| 2025 | 7 | 258 | 0 | 1,799 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Rhinoguard is a nasal endotracheal tube introducer/dilator designed to allow the passage of a nasal endotracheal tube from the nares to the oropharynx.
The device can be used with cuffed and non-cuffed nasal endotracheal tubes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141747 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141747: Rhinoguard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141747
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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