510(k) · Cleared
Recalled · Class II · 2016Anspach Xmax, EMAX2 and EMAX2 Plus System with Otologic Attachment System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Anspach Effort, Inc. · ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Cleared on Dec 31, 2013 as substantially equivalent to K965080 (The Anspach Effort, Inc., 1997) and 2 other predicates after a 259-day review. Its family tree reaches back 3 generations to 2000. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Dec 31, 2013
- Review
- 259 days
- Class
- Class II
- Product code
- ERL
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 3 generations to K002224 (2000). 6 ancestors in all, the oldest K965080 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK002224 XPS 3000 SystemMedtronic Xomed · 2000
- 2 generations backK041413 XPS 3000 SystemMedtronic Xomed, Inc. · 2004
- 1 generation backK073255 XPS 3000 SystemMedtronic Xomed, Inc. · 2008
- This deviceK131053 Anspach Xmax, EMAX2 and EMAX2 Plus System with Otologic Attachment…The Anspach Effort, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK180063 OCM-G1 AttachmentThe Anspach Effort, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K180063OCM-G1 AttachmentThe Anspach Effort, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002224 | XPS 3000 System | Medtronic Xomed | 2000 | — |
| −2 | K041413 | XPS 3000 System | Medtronic Xomed, Inc. | 2004 | — |
| −1 | K073255 | XPS 3000 System | Medtronic Xomed, Inc. | 2008 | — |
| 0 (this device) | K131053 | Anspach Xmax, EMAX2 and EMAX2 Plus System with Otologic Attachment System | The Anspach Effort, Inc. | 2013 | — |
| +1 | K180063 | OCM-G1 Attachment | The Anspach Effort, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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? (3)
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 |
|---|---|---|---|
| * | K965080 | Anspach Micromax SystemSummary page 1…ills are identical to the currently marketed electric and pneumatic surgical drills: * ANSPACHO XMax Pneumatic System cleared via K965080 * ANSPACH'eMax 2 and eMax2 Plus Electric Systems cleared via K011444… | 1997 |
| * | K011444 | Anspach Emax Drill SystemSummary page 1…* ANSPACHO XMax Pneumatic System cleared via K965080 * ANSPACH'eMax 2 and eMax2 Plus Electric Systems cleared via K011444 The Otologic Curved Micro (0CM) Attachment and 0CM Burr Support Sleeves are substantiall… | 2001 |
| * | K073255 | XPS 3000 SystemSummary page 1…handpiece and burrs associated wvith the: *Medtronic. Inc., XPS® 3000 System cleared most recently via K073255 on March 24, 2008 Continued on next page… | 2008 |
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 |
|---|---|---|---|
| K180063 | OCM-G1 Attachment | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 6, 2016 | Class II | Z-2016-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Mar 28, 2016 | Class II | Z-1667-2016 | Process control | Certain lots of the Otologic Curved Micro (OCM) Diamond Ball Burrs may be missing the diamond coating and the ball may be the incorrect size. |
| Mar 28, 2016 | Class II | Z-1668-2016 | Process control | Certain lots of the Otologic Curved Micro (OCM) Diamond Ball Burrs may be missing the diamond coating and the ball may be the incorrect size. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K180063 (The Anspach Effort, Inc., 2018) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K965080.
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. 2013, this device’s year, is highlighted.
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 ANSPACH XMax Pneumatic and eMax 2 and eMax2 Plus Electric Systems are intended for cutting and shaping bone including spine and cranium.
When used with the ANSPACH Systems, the 0CM Attachment and 0CM Bunr Support Sleeves are intended for cutting and shaping bone primarily in otology procedures such as cochicostomies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131053 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131053: Anspach Xmax, EMAX2 and EMAX2 Plus System with Otologic Attachment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131053
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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