510(k) · Cleared
ClearedReinforced Silicone Tracheal Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Portex, Inc. · BTR Tube, Tracheal (W/Wo Connector)
Cleared on Mar 8, 1983 after a 33-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Mar 8, 1983
- Review
- 33 days
- Class
- Class II
- Product code
- BTR
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK830352 Reinforced Silicone Tracheal TubePortex, Inc. · 1983
- Descendant · cites it directly · 0 of its ownK060094 Arcadia Medical Silicone Wire Reinforced Endotracheal TubesArcadia Medical Corporation · 2006
- Descendant · cites it directly · 0 of its ownK955495 Rusch Reinforced Trachael Tube Cuffed, SterileRusch, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK954585 Rusch Pediatric Reinforced Traheal (or Endotracheal) Tube -…Rusch Intl. · 1996
Most influential descendants
Showing 3 of 3 · See all- K060094Arcadia Medical Silicone Wire Reinforced Endotracheal TubesArcadia Medical Corporation · 2006 · cites it directly0descendants
- K955495Rusch Reinforced Trachael Tube Cuffed, SterileRusch, Inc. · 1996 · cites it directly0descendants
- K954585Rusch Pediatric Reinforced Traheal (or Endotracheal) Tube - Uncuffed, SterileRusch Intl. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K830352 | Reinforced Silicone Tracheal Tube | Portex, Inc. | 1983 | — |
| +1 | K060094 | Arcadia Medical Silicone Wire Reinforced Endotracheal Tubes | Arcadia Medical Corporation | 2006 | — |
| +1 | K955495 | Rusch Reinforced Trachael Tube Cuffed, Sterile | Rusch, Inc. | 1996 | — |
| +1 | K954585 | Rusch Pediatric Reinforced Traheal (or Endotracheal) Tube - Uncuffed, Sterile | Rusch Intl. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 12.6 · 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K060094 (Arcadia Medical Corporation, 2006) has gone furthest, with 0 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K830352 · printed Nov 3, 2026
Cite this page
510(k) Report. “K830352: Reinforced Silicone Tracheal Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K830352
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026