510(k) · Cleared
ClearedSkytron Model 860 and 800 Comp. Surgita Neuro Equi
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Skytron, Div. the Kmw Group, Inc. · HBN Chair, Neurosurgical
Cleared on Sep 4, 1990 after a 216-day review. FDA has not posted a summary or statement for it, so its predicates are not known.
- Decided
- Sep 4, 1990
- Review
- 216 days
- Class
- Class I
- Product code
- HBN
- Recalls
- None
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HBN? 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 has not posted a summary or statement for it, so its predicates are not known.
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 HBN devicesHBN Chair, Neurosurgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HBN
FDA has decided no HBN device since 2007.
Median 510(k) review, days · HBN
Too few HBN 510(k)s in any year since 2007 to give a median.
Recalls per year · HBN
No recall names HBN since 2007.
Adverse event reports per year · HBN
2in 2020
MAUDE reports naming product code HBN, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 9 |
| 2018 | 0 | — | 0 | 11 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K900472 · printed Nov 6, 2026
Cite this page
510(k) Report. “K900472: Skytron Model 860 and 800 Comp. Surgita Neuro Equi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K900472
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026