510(k) · Cleared
ClearedSeptAlign (SPLN001)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spirair, Inc. · NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Cleared on Jul 30, 2026 as substantially equivalent to K251790 (Spirair, Inc., 2026) after a 155-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- Jul 30, 2026
- Review
- 155 days
- Class
- Class II
- Product code
- NHB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K922489 (1992). 13 ancestors in all, the oldest K901456 (1990). No later device cites it as a predicate yet.
- Root · 6 generations backK922489 Medpor Surg Implant Material:Prefor Cran/Fac ImplaPorex Technologies Corp. · 1992 · Recalled
- 5 generations backK083621 Medpor Customized Surgical ImplantPorex Surgical, Inc. · 2009
- 4 generations backK132920 Spirox Inex DeviceSpirox, Inc. · 2014
- 3 generations backK223167 Spirair Nasal Septal StrapSpirair, Inc. · 2023
- 2 generations backK233569 SeptAlignSpirair, Inc. · 2024
- 1 generation backK251790 SeptAlignSpirair, Inc. · 2026
- This deviceK260620 SeptAlign (SPLN001)Spirair, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K922489 | Medpor Surg Implant Material:Prefor Cran/Fac Impla | Porex Technologies Corp. | 1992 | 1 |
| −5 | K083621 | Medpor Customized Surgical Implant | Porex Surgical, Inc. | 2009 | — |
| −4 | K132920 | Spirox Inex Device | Spirox, Inc. | 2014 | — |
| −3 | K223167 | Spirair Nasal Septal Strap | Spirair, Inc. | 2023 | — |
| −2 | K233569 | SeptAlign | Spirair, Inc. | 2024 | — |
| −1 | K251790 | SeptAlign | Spirair, Inc. | 2026 | — |
| 0 (this device) | K260620 | SeptAlign (SPLN001) | Spirair, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 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 NHB? 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 NHB device
- #1 K251790 SeptAlignscore 14.9 · 5 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 |
|---|---|---|---|
| * | K251790 | SeptAlignSummary page 5…NHB Regulation Number: 21 CFR 874.3620 III. PREDICATE/REFERENCE DEVICE Predicate Device: SeptAlign (K251790) IV. DEVICE DESCRIPTION SeptAlign consists of a bioabsorbable implant and single use delivery device.… | 2026 |
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?
- The line of descent spans 34 years and passes through 4 companies; a new generation was cleared every 5.3 years on median.
- 2 of the 13 ancestors have a recall of any class.
How does its category compare?
All NHB devicesNHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · NHB
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · NHB
Too few NHB 510(k)s in any year since 2007 to give a median.
Recalls per year · NHB
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHB
22in 2025
MAUDE reports naming product code NHB, 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 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 1 | — | 0 | 8 |
| 2016 | 1 | — | 0 | 9 |
| 2017 | 0 | — | 0 | 22 |
| 2018 | 0 | — | 0 | 17 |
| 2019 | 2 | — | 1 | 27 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 16 |
| 2022 | 1 | — | 0 | 9 |
| 2023 | 1 | — | 0 | 8 |
| 2024 | 1 | — | 0 | 19 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
SeptAlign is used to support and straighten deviations in septal cartilage when sufficient healthy cartilage exists, and the cartilage is appropriately mobilized utilizing standard septoplasty techniques.
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/K260620 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260620: SeptAlign (SPLN001).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260620
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026