510(k) · Cleared
ClearedXPS Drill System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xomed, Inc. · ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Cleared on Oct 21, 1998 as substantially equivalent to K904850 (Micro Motors, Inc., 1991) and 1 other predicate after a 37-day review. Its family tree reaches back 2 generations to 1979.
- Decided
- Oct 21, 1998
- Review
- 37 days
- Class
- Class II
- Product code
- ERL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K791407 (1979). 4 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 | K791407 | Womed Nicro-Craft Power System | Xomed, Inc. | 1979 | — |
| −1 | K960853 | Ace System | Xomed, Inc. | 1996 | — |
| 0 (this device) | K983224 | XPS Drill System | Xomed, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 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 ERL? 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? (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 |
|---|---|---|---|
| * | K904850 | Dual and Single Irr. Systems Models 29550 & 29555Summary page 2…in the ear, nose, throat and other areas of the head and neck. Substantial Equivalence The new XPS Drill System is the same drill system that was previously cleared by K904850. Xomed now intends to market this systcm for ENT and Head and Neck surgery In so doing, we have made some minor changes to the la… | 1991 |
| * | K960853 | Ace SystemSummary page 2…e significant and are typical of any ENT drill. As an ENT drill, the XPS Drill System is also substantially equivalent to the MPS Powerforma currently markcted by Xomed (K960853). Information from the MPS Powerforma manual was used in modifying the Micro Motors manual for the proposed XPS Drill. /00 ===… | 1996 |
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 19 years and passes through 1 company; a new generation was cleared every 16.6 years on median.
- None of the 4 ancestors has a recall.
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 | — |
What is it indicated for?
The XPS Drill System is intended for the controlled incision or removal of bone in the ear, nose, throat and other areas of the head and neck.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983224 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983224: XPS Drill System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983224
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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