510(k) · Cleared
ClearedSilimed Nasal Retainer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Silimed, LLC · LYA Splint, Intranasal Septal
Cleared on Apr 2, 1998 as substantially equivalent to K972151 (Boston Medical Products, Inc., 1997) and 1 other predicate after a 70-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Apr 2, 1998
- Review
- 70 days
- Class
- Class I
- Product code
- LYA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K972151 (1997). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK972151 Doyle Combo Nasal Airway SplintBoston Medical Products, Inc. · 1997
- This deviceK980221 Silimed Nasal RetainerSilimed, LLC · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972151 | Doyle Combo Nasal Airway Splint | Boston Medical Products, Inc. | 1997 | — |
| 0 (this device) | K980221 | Silimed Nasal Retainer | Silimed, LLC | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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? (2)
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 |
|---|---|---|---|
| * | K972151 | Doyle Combo Nasal Airway SplintSummary page 1…restricts this device to sale by or on the order of a physician. Predicate Device: Company Product 510(k)Number Boston Medical Products Doyle Combo Nasal Airway Splint K972151 Boston Medical Preducts Bivalve Nasal Splint K972096 Submitted by: E.J.Smith, Consultant Date: ALY . ot 4, A l… | 1997 |
| * | K972096 | Bivalve Nasal SplintSummary page 1…physician. Predicate Device: Company Product 510(k)Number Boston Medical Products Doyle Combo Nasal Airway Splint K972151 Boston Medical Preducts Bivalve Nasal Splint K972096 Submitted by: E.J.Smith, Consultant Date: ALY . ot 4, A l/(’ SERVICE, » -y ’_/C DEPARTMENT OF HEALTH & HUMAN… | 1997 |
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?
- None of the 2 ancestors has a recall.
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?
The Silimed Nasal Retainer is designed for use after aesthetic and reconstructive rhinoplasty, after rhinoseptoplasty, after rhinoseptocheiloplasty and/or primary and secondary rhinocheiloplasty (cleft-lip nose patients).
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/K980221 · printed Nov 5, 2026
Cite this page
510(k) Report. “K980221: Silimed Nasal Retainer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980221
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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