510(k) · Cleared
ClearedSPIWay Endonasal Access Guide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spiway, LLC · LYA Splint, Intranasal Septal
Cleared on Feb 16, 2018 as substantially equivalent to K153686 (Spiway, LLC, 2016) after a 29-day review. Its family tree reaches back 2 generations to 2014. 1 later device descends from it.
- Decided
- Feb 16, 2018
- Review
- 29 days
- Class
- Class I
- Product code
- LYA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K132721 (2014). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK132721 Spiway Endonasal Access GuideSpiway, LLC · 2014
- 1 generation backK153686 SPIWay Endonasal Access GuideSpiway, LLC · 2016
- This deviceK180141 SPIWay Endonasal Access GuideSpiway, LLC · 2018
- Descendant · cites it directly · 0 of its ownK213153 SPIWay Endonasal Access GuideSpiway, LLC · 2021
Most influential descendants
Showing 1 of 1 · See all- K213153SPIWay Endonasal Access GuideSpiway, LLC · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K132721 | Spiway Endonasal Access Guide | Spiway, LLC | 2014 | — |
| −1 | K153686 | SPIWay Endonasal Access Guide | Spiway, LLC | 2016 | — |
| 0 (this device) | K180141 | SPIWay Endonasal Access Guide | Spiway, LLC | 2018 | — |
| +1 | K213153 | SPIWay Endonasal Access Guide | Spiway, LLC | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 LYA? 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 LYA device
- #1 K243655 TurbAlignscore 10.0 · 2 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 |
|---|---|---|---|
| * | K153686 | SPIWay Endonasal Access GuideSummary page 4…sal splint, 874.4780 Product code LYA 3. IDENTIFICATION OF PREDICATE DEVICES SPIWay Endonasal Access Guide (K153686). 4. DESCRIPTION OF THE DEVICE The SPIWay®Endonasal Access Guide is a temporary working channel sheath for use in endo… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213153 | SPIWay Endonasal Access Guide | 2021 | 0 |
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 4 years and passes through 1 company; a new generation was cleared every 2.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K213153 (Spiway, LLC, 2021) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LYA devicesLYA Splint, Intranasal Septal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · LYA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LYA
104in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LYA
No recall names LYA since 2007.
Adverse event reports per year · LYA
1in 2025
MAUDE reports naming product code LYA, 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 | — | 0 | 2 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 5 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 16 |
| 2012 | 1 | — | 0 | 16 |
| 2013 | 2 | — | 0 | 1 |
| 2014 | 5 | 104 | 0 | 4 |
| 2015 | 0 | — | 0 | 28 |
| 2016 | 1 | — | 0 | 28 |
| 2017 | 2 | — | 0 | 10 |
| 2018 | 2 | — | 0 | 19 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 1 | — | 0 | 6 |
| 2021 | 1 | — | 0 | 19 |
| 2022 | 0 | — | 0 | 8 |
| 2023 | 1 | — | 0 | 17 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SPIWay® Endonasal Access Guide is indicated for use in endoscopic sphenoid sinus and transsphenoidal surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180141 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180141: SPIWay Endonasal Access Guide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180141
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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