510(k) · Cleared
ClearedXPS Curved Bur
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Xomed, Inc. · EQJ Bur, Ear, Nose And Throat
Cleared on Aug 12, 2004 after a 20-day review. The FDA summary names its predicate without a number.
- Decided
- Aug 12, 2004
- Review
- 20 days
- Class
- Class I
- Product code
- EQJ
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 EQJ? 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? (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 |
|---|---|---|---|
| * | — | ENT Bur Named without a submission number |
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 EQJ devicesEQJ Bur, Ear, Nose And Throat: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EQJ
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · EQJ
Too few EQJ 510(k)s in any year since 2007 to give a median.
Recalls per year · EQJ
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EQJ
435in 2025
MAUDE reports naming product code EQJ, 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 | 21 |
| 2008 | 0 | — | 0 | 21 |
| 2009 | 0 | — | 0 | 10 |
| 2010 | 0 | — | 0 | 30 |
| 2011 | 0 | — | 0 | 65 |
| 2012 | 0 | — | 0 | 84 |
| 2013 | 0 | — | 0 | 76 |
| 2014 | 0 | — | 0 | 95 |
| 2015 | 0 | — | 0 | 93 |
| 2016 | 0 | — | 0 | 95 |
| 2017 | 1 | — | 0 | 118 |
| 2018 | 0 | — | 0 | 204 |
| 2019 | 0 | — | 0 | 129 |
| 2020 | 0 | — | 0 | 100 |
| 2021 | 0 | — | 1 | 131 |
| 2022 | 0 | — | 0 | 229 |
| 2023 | 0 | — | 0 | 261 |
| 2024 | 0 | — | 0 | 368 |
| 2025 | 0 | — | 0 | 435 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The XPS Curved Bur is intended for use in an ear, nose, and throat electric or pneumatic surgical drill for incising or removing bone in the ear, nose, or throat area, and is an accessory to the XPS 3000 System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041985 · printed Nov 3, 2026
Cite this page
510(k) Report. “K041985: XPS Curved Bur.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K041985
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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