510(k) · Cleared
ClearedSheridan Spiral-Flex Endotracheal Tubes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflexmedical, Inc. · BTR Tube, Tracheal (W/Wo Connector)
Cleared on Dec 6, 2019 as substantially equivalent to K844296 (Sheridan Catheter Corp., 1984) and 1 other predicate after a 101-day review. Its family tree reaches back 1 generation to 1984.
- Decided
- Dec 6, 2019
- Review
- 101 days
- Class
- Class II
- Product code
- BTR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K844296 (1984). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK844296 Tracheal Tube, Reinforced, CuffedSheridan Catheter Corp. · 1984
- This deviceK192324 Sheridan Spiral-Flex Endotracheal TubesTeleflexmedical, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K844296 | Tracheal Tube, Reinforced, Cuffed | Sheridan Catheter Corp. | 1984 | — |
| 0 (this device) | K192324 | Sheridan Spiral-Flex Endotracheal Tubes | Teleflexmedical, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 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? (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 |
|---|---|---|---|
| * | K844296 | Tracheal Tube, Reinforced, CuffedSummary page 4…n Panel: Anesthesiology E. Predicate Device This submission demonstrates substantial equivalence to the predicate device: Sheridan Reinforced Tracheal Tube K844296 and Spiral-Flex Tracheal Tube K860105 F. Device Description The Sheridan Spiral-Flex Endotracheal Tubes are spiral reinforced t… | 1984 |
| * | K860105 | Spiral-FlexSummary page 4…cate Device This submission demonstrates substantial equivalence to the predicate device: Sheridan Reinforced Tracheal Tube K844296 and Spiral-Flex Tracheal Tube K860105 F. Device Description The Sheridan Spiral-Flex Endotracheal Tubes are spiral reinforced tracheal tubes that are inserted into t… | 1986 |
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?
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K844296.
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. 2019, 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?
Sheridan cuffed, uncuffed and reinforced tracheal tubes are designed for oral or nasal intubation and are indicated for airway management.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192324 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192324: Sheridan Spiral-Flex Endotracheal Tubes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192324
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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