510(k) · Cleared
ClearedAce System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xomed, Inc. · EQJ Bur, Ear, Nose And Throat
Cleared on Apr 3, 1996 as substantially equivalent to K791407 (Xomed, Inc., 1979) and 1 other predicate after a 33-day review. Its family tree reaches back 1 generation to 1979. 1 later device descends from it.
- Decided
- Apr 3, 1996
- Review
- 33 days
- Class
- Class I
- Product code
- EQJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K791407 (1979). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K983224XPS Drill SystemXomed, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K791407 | Womed Nicro-Craft Power System | Xomed, Inc. | 1979 | — |
| 0 (this device) | K960853 | Ace System | Xomed, Inc. | 1996 | — |
| +1 | K983224 | XPS Drill System | Xomed, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 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? (5)
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 |
|---|---|---|---|
| * | K791407 | Womed Nicro-Craft Power SystemSummary page 2…alent features (irrigation, handpiece styles, etc.) and performance characteristics (speed and torque): DEVICE Manufacturer 510K Number Micro-Crafi® Power System Xomed K791407 Synergy™ Smith & Nephew - Richards unknown Jedmed Otologic Drill Bien-Aire unknown (Marketed by Jedmed) UltraPower™Complete Ha… | 1979 |
| * | K926547 | Mednext 1000 Bone Dissecting SystemSummary page 2…rds unknown Jedmed Otologic Drill Bien-Aire unknown (Marketed by Jedmed) UltraPower™Complete Hall Surgical / Zimmer unknown Drill System Bone Dissecting System Med"™ K926547 Discussion of Differences There are no substantial differences between the ACE System and the equivalent electrical drill syste… | 1993 |
| * | — | Synergy™ Named without a submission number | |
| * | — | Jedmed Otologic Drill Named without a submission number | |
| * | — | UltraPower™ Complete Drill System Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K983224 | XPS Drill System | 1998 | 0 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K983224 (Xomed, Inc., 1998) has gone furthest, with 0 descendants of its own.
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 ACE System is primarily intended for the controlled incision or removal of bone in the ear, nose, throat and other areas of the head and neck. It also has applications in neurosurgery (e.g. cervical laminectomies), hand surgery, and plastic surgery (e.g. facial and mandibular reconstruction)
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/K960853 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960853: Ace System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960853
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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