510(k) · Cleared
ClearedNeurosplint
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurospectrum, LLC · IQI Orthosis, Limb Brace
Cleared on Aug 13, 2015 after a 252-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 13, 2015
- Review
- 252 days
- Class
- Class I
- Product code
- IQI
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IQI? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All IQI devicesIQI Orthosis, Limb Brace: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · IQI
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · IQI
Too few IQI 510(k)s in any year since 2007 to give a median.
Recalls per year · IQI
3in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IQI
8in 2025
MAUDE reports naming product code IQI, 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 | 0 | — | 0 | 5 |
| 2008 | 0 | — | 0 | 12 |
| 2009 | 0 | — | 0 | 33 |
| 2010 | 0 | — | 0 | 12 |
| 2011 | 0 | — | 0 | 16 |
| 2012 | 0 | — | 0 | 31 |
| 2013 | 0 | — | 0 | 36 |
| 2014 | 0 | — | 0 | 39 |
| 2015 | 1 | — | 0 | 20 |
| 2016 | 0 | — | 2 | 14 |
| 2017 | 0 | — | 0 | 93 |
| 2018 | 0 | — | 2 | 19 |
| 2019 | 0 | — | 0 | 19 |
| 2020 | 0 | — | 0 | 11 |
| 2021 | 0 | — | 0 | 9 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 3 | 3 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
An orthosis worn on the wrist
With rigid insert:
to limit wrist motion while worn, allowing the body to recover from the damage of repetitive motion or other injuries
to immobilize and / or support for functional improvement following, repetitive motion-type of injuries such as carpal tunnel syndrome (CTS), wrist strains or sprains, and similar injuries of the wrist
Without rigid insert:
to provide wrist support
to provide temporary relief of associated symptoms of some repetitive motion wrist conditions
to provide feedback to the user when the wrist reaches maximal flexion or extension
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K143458 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143458: Neurosplint.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143458
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026