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 Jan 28, 2016 as substantially equivalent to K132721 (Spiway, LLC, 2014) after a 36-day review. Its family tree reaches back 1 generation to 2014. 2 later devices descend from it.
- Decided
- Jan 28, 2016
- Review
- 36 days
- Class
- Class I
- Product code
- LYA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K132721 (2014). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK132721 Spiway Endonasal Access GuideSpiway, LLC · 2014
- This deviceK153686 SPIWay Endonasal Access GuideSpiway, LLC · 2016
- Descendant · cites it directly · 1 of its ownK180141 SPIWay Endonasal Access GuideSpiway, LLC · 2018
- Descendant · 2 generations on · 0 of its ownK213153 SPIWay Endonasal Access GuideSpiway, LLC · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K132721 | Spiway Endonasal Access Guide | Spiway, LLC | 2014 | — |
| 0 (this device) | K153686 | SPIWay Endonasal Access Guide | Spiway, LLC | 2016 | — |
| +1 | K180141 | SPIWay Endonasal Access Guide | Spiway, LLC | 2018 | — |
| +2 | K213153 | SPIWay Endonasal Access Guide | Spiway, LLC | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K132721 | Spiway Endonasal Access GuideSummary page 4…sal splint, 874.4780 Product code LYA 3. IDENTIFICATION OF PREDICATE DEVICES SPIWay Endonasal Access Guide (K132721) 4. DESCRIPTION OF THE DEVICE The SPIWay Endonasal Access Guide is a sterile, single patient use device placed… | 2014 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180141 | SPIWay Endonasal Access Guide | 2018 | 1 |
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?
- Its one ancestor has no recall.
- Of its descendants, K180141 (Spiway, LLC, 2018) has gone furthest, with 1 descendant 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. 2016, 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/K153686 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153686: 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/K153686
Report an extraction error
Are you the manufacturer?
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