510(k) · Cleared
ClearedCustom Nasal Splint
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Medical Products, Inc. · LYA Splint, Intranasal Septal
Cleared on Jul 3, 1997 after a 29-day review. The FDA summary names its predicate without a number. 48 later devices descend from it.
- Decided
- Jul 3, 1997
- Review
- 29 days
- Class
- Class I
- Product code
- LYA
- Recalls
- None
- Predicates
- 0
48 later devices descend from it, 1 citing it directly.
- This deviceK972082 Custom Nasal SplintBoston Medical Products, Inc. · 1997
- Descendant · cites it directly · 47 of its ownK012532 Sepragel SinusGenzyme Corp. · 2001
- Descendant · 2 generations on · 29 of its ownK033666 HemadermMedafor, Inc. · 2003
- Descendant · 3 generations on · 28 of its ownK070211 Traumarrest and Bleedarrest Hemostatic Particles and FoamHemostasis, LLC · 2007
- Descendant · 4 generations on · 19 of its ownK072900 Excelarrest FoamHemostasis, LLC · 2007
- Descendant · 2 generations on · 17 of its ownK052099 Nasopore Nasal Dressing, Model Ndox-Yyy/ZZPolyganics B.V., · 2005
Showing 5 of 48 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 48 · See all- K012532Sepragel SinusGenzyme Corp. · 2001 · cites it directly47descendants
- K033666HemadermMedafor, Inc. · 2003 · 2 generations on29descendants
- K070211Traumarrest and Bleedarrest Hemostatic Particles and FoamHemostasis, LLC · 2007 · 3 generations on28descendants
- K072900Excelarrest FoamHemostasis, LLC · 2007 · 4 generations on19descendants
- K052099Nasopore Nasal Dressing, Model Ndox-Yyy/ZZPolyganics B.V., · 2005 · 2 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972082 | Custom Nasal Splint | Boston Medical Products, Inc. | 1997 | — |
| +1 | K012532 | Sepragel Sinus | Genzyme Corp. | 2001 | — |
| +2 | K033666 | Hemaderm | Medafor, Inc. | 2003 | — |
| +3 | K070211 | Traumarrest and Bleedarrest Hemostatic Particles and Foam | Hemostasis, LLC | 2007 | — |
| +4 | K072900 | Excelarrest Foam | Hemostasis, LLC | 2007 | — |
| +2 | K052099 | Nasopore Nasal Dressing, Model Ndox-Yyy/ZZ | Polyganics B.V., | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 5 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 6 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | — | Product Nos. 20-10670, 20-10675, 20-10685, 20-10682, 20-10680, and 20-10686 manufactured… Named without a submission number |
What descends from it? (48)
See all 481 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012532 | Sepragel Sinus | 2001 | 47 |
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, K012532 (Genzyme Corp., 2001) has gone furthest, with 47 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.
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?
To provide septal support and reduce or prevent adhesions between the
septum and lateral nasal wall following surgery.
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/K972082 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972082: Custom Nasal Splint.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972082
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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