510(k) · Cleared
Clearedallay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tulavi Therapeutics, Inc. · SBG In Situ Polymerizing Peripheral Nerve Cap
Cleared on Sep 29, 2025 as substantially equivalent to DEN230061 (Tulavi Therapeutics, 2024) after a 90-day review. Its family tree reaches back 1 generation to 2024.
- Decided
- Sep 29, 2025
- Review
- 90 days
- Class
- Class II
- Product code
- SBG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN230061 (2024). No later device cites it as a predicate yet.
- Root · 1 generation backDEN230061 allay Nerve CapTulavi Therapeutics · 2024
- This deviceK252051 allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery…Tulavi Therapeutics, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN230061 | allay Nerve Cap | Tulavi Therapeutics | 2024 | — |
| 0 (this device) | K252051 | allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627) | Tulavi Therapeutics, Inc. | 2025 | — |
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 SBG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | DEN230061 | allay Nerve CapSummary page 5…21 CFR §880.5260 Product Code(s): SBG Predicate Name: allay™ Nerve Cap Predicate Number: DEN230061 Predicate Product Code: SBG 510(k) Notification Summary… | 2024 |
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?
- Its one ancestor has no recall.
How does its category compare?
All SBG devicesSBG In Situ Polymerizing Peripheral Nerve Cap: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · SBG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SBG
Too few SBG 510(k)s in any year since 2007 to give a median.
Recalls per year · SBG
No recall names SBG since 2007.
Adverse event reports per year · SBG
No MAUDE report names SBG since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The allay™ Nerve Cap is indicated for use in individuals weighing 25 kg or more as a physical barrier to
separate the peripheral nerve end from the surrounding environment to reduce the risk of the
development of a symptomatic neuroma.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K252051 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252051: allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252051
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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