510(k) · Cleared
ClearedXPS 3000 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Xomed · ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Cleared on Dec 4, 2000 after a 133-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 466 devices in its family, counting itself, has a Class I recall. 465 later devices descend from it.
- Decided
- Dec 4, 2000
- Review
- 133 days
- Class
- Class II
- Product code
- ERL
- Recalls
- None
- Predicates
- 0
465 later devices descend from it, 3 citing it directly. 1 of the 466 devices in this family, counting this one, has a Class I recall.
- This deviceK002224 XPS 3000 SystemMedtronic Xomed · 2000
- Descendant · cites it directly · 459 of its ownK041523 XPS 3000 SystemMedtronic Xomed, Inc. · 2004
- Descendant · cites it directly · 453 of its ownK041413 XPS 3000 SystemMedtronic Xomed, Inc. · 2004
- Descendant · cites it directly · 448 of its ownK073255 XPS 3000 SystemMedtronic Xomed, Inc. · 2008
- Descendant · 2 generations on · 443 of its ownK081475 Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System…Medtronic Xomed, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 420 of its ownK081277 XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Medtronic Xomed, Inc. · 2008 · Recalled
Showing 5 of 465 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub8 generations on · 2021
Most influential descendants
Showing 5 of 465 · See all- K041523XPS 3000 SystemMedtronic Xomed, Inc. · 2004 · cites it directly459descendants
- K041413XPS 3000 SystemMedtronic Xomed, Inc. · 2004 · cites it directly453descendants
- K073255XPS 3000 SystemMedtronic Xomed, Inc. · 2008 · cites it directly448descendants
- K081475Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Medtronic Xomed, Inc. · 2008 · 2 generations on443descendants
- K081277XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc)Medtronic Xomed, Inc. · 2008 · 2 generations on420descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002224 | XPS 3000 System | Medtronic Xomed | 2000 | — |
| +1 | K041523 | XPS 3000 System | Medtronic Xomed, Inc. | 2004 | — |
| +1 | K041413 | XPS 3000 System | Medtronic Xomed, Inc. | 2004 | — |
| +1 | K073255 | XPS 3000 System | Medtronic Xomed, Inc. | 2008 | — |
| +2 | K081475 | Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System… | Medtronic Xomed, Inc. | 2008 | 3 |
| +2 | K081277 | XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc) | Medtronic Xomed, Inc. | 2008 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 7 | 0 |
| 2014 | 3 | 0 |
| 2015 | 8 | 0 |
| 2016 | 10 | 0 |
| 2017 | 16 | 0 |
| 2018 | 19 | 0 |
| 2019 | 27 | 0 |
| 2020 | 23 | 0 |
| 2021 | 43 | 1 |
| 2022 | 49 | 0 |
| 2023 | 63 | 0 |
| 2024 | 66 | 0 |
| 2025 | 65 | 0 |
| 2026 | 56 | 0 |
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.
1 device in this family has a Class I recall. 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 ERL device
- #1 K243280 Piezomed Pro (Piezomed Pro module M-PM100…score 12.0 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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? (465)
See all 4653 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 8 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K041523 (Medtronic Xomed, Inc., 2004) has gone furthest, with 459 descendants of its own.
How does its category compare?
All ERL devicesERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ERL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ERL
191in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ERL
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ERL
1,469in 2025
MAUDE reports naming product code ERL, 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 | 112 |
| 2008 | 6 | 181 | 0 | 60 |
| 2009 | 1 | — | 1 | 249 |
| 2010 | 0 | — | 0 | 444 |
| 2011 | 0 | — | 0 | 1,068 |
| 2012 | 2 | — | 0 | 1,379 |
| 2013 | 2 | — | 3 | 3,231 |
| 2014 | 1 | — | 0 | 1,975 |
| 2015 | 3 | 86 | 0 | 2,630 |
| 2016 | 4 | 180 | 0 | 1,455 |
| 2017 | 2 | — | 0 | 999 |
| 2018 | 1 | — | 0 | 1,380 |
| 2019 | 1 | — | 0 | 2,515 |
| 2020 | 1 | — | 5 | 2,369 |
| 2021 | 1 | — | 1 | 2,283 |
| 2022 | 3 | 191 | 0 | 1,574 |
| 2023 | 0 | — | 0 | 1,725 |
| 2024 | 1 | — | 0 | 1,588 |
| 2025 | 1 | — | 0 | 1,469 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K002224 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002224: XPS 3000 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002224
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026