510(k) · Cleared
ClearedBaxano Ultra Low Profile Rongeur
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxano, Inc. · HAE Rongeur, Manual
Cleared on Mar 4, 2008 after an 11-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Mar 4, 2008
- Review
- 11 days
- Class
- Class II
- Product code
- HAE
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK080494 Baxano Ultra Low Profile RongeurBaxano, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK100958 Modification to: Microblade Shaver and AccessoriesBaxano, Inc. · 2010
- Descendant · cites it directly · 2 of its ownK081742 Baxano Neural Localization Probe 1.75 and 1.25Baxano, Inc. · 2008
- Descendant · 2 generations on · 1 of its ownK092729 Baxano Neuro Check DeviceBaxano, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK113533 Neuro Check Device with IO-Flex WireBaxano, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK110696 Neuro Check Device with IO-Flex WireBaxano, Inc. · 2011
Most influential descendants
Showing 5 of 5 · See all- K100958Modification to: Microblade Shaver and AccessoriesBaxano, Inc. · 2010 · cites it directly2descendants
- K081742Baxano Neural Localization Probe 1.75 and 1.25Baxano, Inc. · 2008 · cites it directly2descendants
- K092729Baxano Neuro Check DeviceBaxano, Inc. · 2009 · 2 generations on1descendant
- K113533Neuro Check Device with IO-Flex WireBaxano, Inc. · 2012 · cites it directly0descendants
- K110696Neuro Check Device with IO-Flex WireBaxano, Inc. · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K080494 | Baxano Ultra Low Profile Rongeur | Baxano, Inc. | 2008 | — |
| +1 | K100958 | Modification to: Microblade Shaver and Accessories | Baxano, Inc. | 2010 | — |
| +1 | K081742 | Baxano Neural Localization Probe 1.75 and 1.25 | Baxano, Inc. | 2008 | — |
| +2 | K092729 | Baxano Neuro Check Device | Baxano, Inc. | 2009 | — |
| +1 | K113533 | Neuro Check Device with IO-Flex Wire | Baxano, Inc. | 2012 | — |
| +2 | K110696 | Neuro Check Device with IO-Flex Wire | Baxano, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | — | Baxano Ultra Low Profile (ULP) Rongeur Named without a submission number |
What descends from it? (5)
3 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?
- Of its descendants, K100958 (Baxano, Inc., 2010) has gone furthest, with 2 descendants of its own.
How does its category compare?
All HAE devicesHAE Rongeur, Manual: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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. Ultra Low Profile Rongeur is 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/K080494 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080494: Baxano Ultra Low Profile Rongeur.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080494
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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