510(k) · Cleared
ClearedNeuro Check Device with IO-Flex Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxano, Inc. · HAE Rongeur, Manual
Cleared on Apr 11, 2012 as substantially equivalent to K063231 (Baxano, Inc., 2007) and 2 other predicates after a 133-day review. Its family tree reaches back 2 generations to 2007.
- Decided
- Apr 11, 2012
- Review
- 133 days
- Class
- Class II
- Product code
- HAE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K063231 (2007). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K063231 | Microblade Shaver and Accessories | Baxano, Inc. | 2007 | — |
| −1 | K100958 | Modification to: Microblade Shaver and Accessories | Baxano, Inc. | 2010 | — |
| 0 (this device) | K113533 | Neuro Check Device with IO-Flex Wire | Baxano, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 HAE? 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 HAE device
- #1 K260446 Tontarra Punches and Rongeursscore 12.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K063231 | Microblade Shaver and AccessoriesSummary page 1…ation: Class 11(21 CFR 882.4840) Product Code: HAE Predicate Device Baxano MicroBlade® Shaver Device and Accessories (K<063231, Information: 1080494,K1100958) Device Description: The MicroBladle Shaver device is comprise… | 2007 |
| * | K080494 | Baxano Ultra Low Profile RongeurSummary page 1…Product Code: HAE Predicate Device Baxano MicroBlade® Shaver Device and Accessories (K<063231, Information: 1080494,K1100958) Device Description: The MicroBladle Shaver device is comprised of a proximal handle,… | 2008 |
| Kept off the family tree | K110958 | FDA’s K110958 is Versajet II Hydrosurgery System Console / Exact Handpieces / Plus Handpieces… Our reading of the summary gave K110958, FDA’s number for Versajet II Hydrosurgery System Console / Exact Handpieces… (Smith & Nephew, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Baxano MicroBlade Shaver Device and Accessories”. Kept off the family tree. | 2011 |
| * | K100958 | Modification to: Microblade Shaver and AccessoriesSummary page 4…The MicroBladle Shaver Device and Accessories are substantially Equivalence: equivalent to the MicroBladle Shaver and Accessories (K100958, cleared on July, 23, 2010). The MicroBladle Shaver and Accessories… | 2010 |
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 5 years and passes through 1 company; a new generation was cleared every 3.3 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K063231.
How does its category compare?
All HAE devicesHAE Rongeur, Manual: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · HAE
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAE
270in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAE
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HAE
10in 2025
MAUDE reports naming product code HAE, 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 | 4 |
| 2008 | 2 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 6 |
| 2010 | 2 | — | 0 | 10 |
| 2011 | 0 | — | 0 | 31 |
| 2012 | 2 | — | 0 | 47 |
| 2013 | 2 | — | 0 | 20 |
| 2014 | 0 | — | 0 | 15 |
| 2015 | 1 | — | 0 | 25 |
| 2016 | 4 | 270 | 0 | 34 |
| 2017 | 0 | — | 0 | 25 |
| 2018 | 1 | — | 0 | 29 |
| 2019 | 0 | — | 0 | 24 |
| 2020 | 2 | — | 0 | 25 |
| 2021 | 1 | — | 0 | 12 |
| 2022 | 2 | — | 0 | 13 |
| 2023 | 2 | — | 2 | 10 |
| 2024 | 0 | — | 0 | 9 |
| 2025 | 1 | — | 0 | 10 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Baxano Inc. MicroBlade Shaver and Accessories are designed for accessing, cutting, and biting soft tissue and bone during surgery involving the spinal column.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113533 · printed Nov 5, 2026
Cite this page
510(k) Report. “K113533: Neuro Check Device with IO-Flex Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K113533
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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