510(k) · Cleared
ClearedNeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nevap, Inc. · BTR Tube, Tracheal (W/Wo Connector)
Cleared on Feb 16, 2018 as substantially equivalent to K090352 (Covidien, 2009) after a 207-day review. Its family tree reaches back 3 generations to 1987.
- Decided
- Feb 16, 2018
- Review
- 207 days
- Class
- Class II
- Product code
- BTR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K871204 (1987). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK871204 Cuffed Tracheal Tube (Multiple)Mallinckrodt Critical Care · 1987 · Recalled
- 2 generations backK082520 Sealguard Evac Endotracheal and Endotracheal TubesMallinckrodt Medical · 2008 · Recalled
- 1 generation backK090352 Taperguard Endotracheal Tubes, Taperguard Evac Endotracheal TubesCovidien · 2009
- This deviceK172208 NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with…Nevap, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K871204 | Cuffed Tracheal Tube (Multiple) | Mallinckrodt Critical Care | 1987 | 1 |
| −2 | K082520 | Sealguard Evac Endotracheal and Endotracheal Tubes | Mallinckrodt Medical | 2008 | 2 |
| −1 | K090352 | Taperguard Endotracheal Tubes, Taperguard Evac Endotracheal Tubes | Covidien | 2009 | — |
| 0 (this device) | K172208 | NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet | Nevap, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 BTR? 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? (1)
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 |
|---|---|---|---|
| * | K090352 | Taperguard Endotracheal Tubes, Taperguard Evac Endotracheal TubesSummary page 5…K172208 Product Code: BTR Device Class: Class II 5.6. Predicate Device: TaperGuard EvacTM Endotracheal Tubes (K090352) 5.7. Device Description: The NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with preloaded stylet is a disp… | 2009 |
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 31 years and passes through 4 companies; a new generation was cleared every 8.9 years on median.
- 2 of the 4 ancestors have a recall of any class.
- 2 other devices also cite its predicate K090352.
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. 2018, 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?
NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet is indicated for oral/tracheal intubation for anesthesia, airway management and removal of accumulated subglottic secretions. It is indicated for single-patient, single-use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172208 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172208: NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172208
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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