510(k) · Cleared
ClearedModification to: Microblade Shaver and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxano, Inc. · HAE Rongeur, Manual
Cleared on Jul 23, 2010 as substantially equivalent to K063231 (Baxano, Inc., 2007) and 1 other predicate after a 107-day review. Its family tree reaches back 1 generation to 2007. 2 later devices descend from it.
- Decided
- Jul 23, 2010
- Review
- 107 days
- Class
- Class II
- Product code
- HAE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K063231 (2007). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK063231 Microblade Shaver and AccessoriesBaxano, Inc. · 2007
- This deviceK100958 Modification to: Microblade Shaver and AccessoriesBaxano, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK113533 Neuro Check Device with IO-Flex WireBaxano, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK110696 Neuro Check Device with IO-Flex WireBaxano, Inc. · 2011
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 |
|---|---|---|---|---|---|
| −1 | K063231 | Microblade Shaver and Accessories | Baxano, Inc. | 2007 | — |
| 0 (this device) | K100958 | Modification to: Microblade Shaver and Accessories | Baxano, Inc. | 2010 | — |
| +1 | K113533 | Neuro Check Device with IO-Flex Wire | Baxano, Inc. | 2012 | — |
| +1 | K110696 | Neuro Check Device with IO-Flex Wire | Baxano, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 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? (2)
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 |
|---|---|---|---|
| * | K063231 | Microblade Shaver and AccessoriesSummary page 1…Rongeur, Manual Classification: Class 11 (21 CFR 882.4840) Product Code: HAE Predicate Device Baxano MicroBlade Shaver and Accessories (K063231) and Information: modified Accessories (K(080494). Device Description: The modified MicroBlade Shaver device… | 2007 |
| * | K080494 | Baxano Ultra Low Profile RongeurSummary page 1….4840) Product Code: HAE Predicate Device Baxano MicroBlade Shaver and Accessories (K063231) and Information: modified Accessories (K(080494). Device Description: The modified MicroBlade Shaver device iscomprised of a proximal handle, ri… | 2008 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All HAE devicesHAE Rongeur, Manual: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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. MicroBladeShaver 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/K100958 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100958: Modification to: Microblade Shaver and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100958
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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