510(k) · Cleared
ClearedSeptAlign
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 Mar 22, 2024 as substantially equivalent to K223167 (Spirair, Inc., 2023) after a 137-day review. Its family tree reaches back 4 generations to 1992. 2 later devices descend from it.
- Decided
- Mar 22, 2024
- Review
- 137 days
- Class
- Class II
- Product code
- NHB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K922489 (1992). 11 ancestors in all, the oldest K901456 (1990). 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK922489 Medpor Surg Implant Material:Prefor Cran/Fac ImplaPorex Technologies Corp. · 1992 · Recalled
- 3 generations backK083621 Medpor Customized Surgical ImplantPorex Surgical, Inc. · 2009
- 2 generations backK132920 Spirox Inex DeviceSpirox, Inc. · 2014
- 1 generation backK223167 Spirair Nasal Septal StrapSpirair, Inc. · 2023
- This deviceK233569 SeptAlignSpirair, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK251790 SeptAlignSpirair, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK260620 SeptAlign (SPLN001)Spirair, Inc. · 2026
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 |
|---|---|---|---|---|---|
| −4 | K922489 | Medpor Surg Implant Material:Prefor Cran/Fac Impla | Porex Technologies Corp. | 1992 | 1 |
| −3 | K083621 | Medpor Customized Surgical Implant | Porex Surgical, Inc. | 2009 | — |
| −2 | K132920 | Spirox Inex Device | Spirox, Inc. | 2014 | — |
| −1 | K223167 | Spirair Nasal Septal Strap | Spirair, Inc. | 2023 | — |
| 0 (this device) | K233569 | SeptAlign | Spirair, Inc. | 2024 | — |
| +1 | K251790 | SeptAlign | Spirair, Inc. | 2026 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K223167 | Spirair Nasal Septal StrapSummary page 4…Regulation Number: 21 CFR 874.3620 III. PREDICATE/REFERENCE DEVICE Predicate Device: Spirair Nasal Septal Strap (K223167) Reference Device: Spirox INEX Absorbable Nasal Implant (K152958) IV. DEVICE DESCRIPTION… | 2023 |
| † | K152958 | INEX Absorbable Nasal Implant | 2015 |
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 |
|---|---|---|---|
| K251790 | SeptAlign | 2026 | 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?
- The line of descent spans 32 years and passes through 4 companies; a new generation was cleared every 9.2 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K251790 (Spirair, Inc., 2026) has gone furthest, with 1 descendant of its own.
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. 2024, 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 minor deviations in septal cartilage when sufficient healthy cartilage exists,
and the cartilage is appropriately mobilized utilizing standard septoplasty techniques.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233569 · printed Nov 4, 2026
Cite this page
510(k) Report. “K233569: SeptAlign.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K233569
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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