510(k) · Cleared
ClearedSpiral-Flex
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sheridan Catheter Corp. · BTR Tube, Tracheal (W/Wo Connector)
Cleared on Mar 4, 1986 after a 50-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- Mar 4, 1986
- Review
- 50 days
- Class
- Class II
- Product code
- BTR
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 3 citing it directly.
- This deviceK860105 Spiral-FlexSheridan Catheter Corp. · 1986
- Descendant · cites it directly · 6 of its ownK051993 Lma Fastrach Ett Single UseThe Laryngeal Mask Co., Ltd. · 2005
- Descendant · 2 generations on · 4 of its ownK130304 Lma Family of AirwaysThe Laryngeal Mask Co., Ltd. · 2014
- Descendant · 3 generations on · 3 of its ownK142103 Cuff Pilot, Sure SealTeleflexmedical, Inc. · 2015
- Descendant · 4 generations on · 1 of its ownK160694 Disposable Endotracheal tube, sterile, AccuCuffTianjin Medis Medical Device Co., Ltd. · 2017
- Descendant · 2 generations on · 0 of its ownK242495 LMA Fastrach ETT SUTeleflex Medical · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K051993Lma Fastrach Ett Single UseThe Laryngeal Mask Co., Ltd. · 2005 · cites it directly6descendants
- K130304Lma Family of AirwaysThe Laryngeal Mask Co., Ltd. · 2014 · 2 generations on4descendants
- K142103Cuff Pilot, Sure SealTeleflexmedical, Inc. · 2015 · 3 generations on3descendants
- K160694Disposable Endotracheal tube, sterile, AccuCuffTianjin Medis Medical Device Co., Ltd. · 2017 · 4 generations on1descendant
- K242495LMA Fastrach ETT SUTeleflex Medical · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K860105 | Spiral-Flex | Sheridan Catheter Corp. | 1986 | — |
| +1 | K051993 | Lma Fastrach Ett Single Use | The Laryngeal Mask Co., Ltd. | 2005 | — |
| +2 | K130304 | Lma Family of Airways | The Laryngeal Mask Co., Ltd. | 2014 | — |
| +3 | K142103 | Cuff Pilot, Sure Seal | Teleflexmedical, Inc. | 2015 | — |
| +4 | K160694 | Disposable Endotracheal tube, sterile, AccuCuff | Tianjin Medis Medical Device Co., Ltd. | 2017 | — |
| +2 | K242495 | LMA Fastrach ETT SU | Teleflex Medical | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2005 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 3 | 0 |
| 2025 | 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? (9)
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, K051993 (The Laryngeal Mask Co., Ltd., 2005) has gone furthest, with 6 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/K860105 · printed Nov 4, 2026
Cite this page
510(k) Report. “K860105: Spiral-Flex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K860105
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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