510(k) · Cleared
Recalled · Class II · 2022Anspach EG1 High Speed System, G1 Attachments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Anspach Effort, Inc. · HBC Motor, Drill, Electric
Cleared on Jan 10, 2014 as substantially equivalent to K011444 (The Anspach Effort, Inc., 2001) after a 46-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it. It has been recalled 11 times.
- Decided
- Jan 10, 2014
- Review
- 46 days
- Class
- Class II
- Product code
- HBC
- Recalls
- 11
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011444 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK011444 Anspach Emax Drill SystemThe Anspach Effort, Inc. · 2001 · Recalled
- This deviceK133604 Anspach EG1 High Speed System, G1 AttachmentsThe Anspach Effort, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK220485 Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless…The Anspach Effort, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K220485Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A…The Anspach Effort, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011444 | Anspach Emax Drill System | The Anspach Effort, Inc. | 2001 | 70 |
| 0 (this device) | K133604 | Anspach EG1 High Speed System, G1 Attachments | The Anspach Effort, Inc. | 2014 | — |
| +1 | K220485 | Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control… | The Anspach Effort, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 HBC? 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 HBC device
- #1 K254174 Surgical Power Systemscore 14.7 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K011444 | Anspach Emax Drill System | 2001 |
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 |
|---|---|---|---|
| K220485 | Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A… | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 7, 2022 | Class II | Z-0917-2023 | Under Investigation by firm | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in… |
| Dec 7, 2022 | Class II | Z-0920-2023 | Under Investigation by firm | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in… |
| Dec 7, 2022 | Class II | Z-0921-2023 | Under Investigation by firm | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in… |
| Dec 7, 2022 | Class II | Z-0916-2023 | Under Investigation by firm | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in… |
| Dec 7, 2022 | Class II | Z-0922-2023 | Under Investigation by firm | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in… |
| Dec 7, 2022 | Class II | Z-0924-2023 | Under Investigation by firm | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in… |
| Dec 7, 2022 | Class II | Z-0918-2023 | Under Investigation by firm | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in… |
| Dec 7, 2022 | Class II | Z-0919-2023 | Under Investigation by firm | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in… |
| Dec 7, 2022 | Class II | Z-0923-2023 | Under Investigation by firm | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in… |
| Jun 15, 2016 | Class II | Z-2253-2016 | Employee error | The graphics at the attachment interface indicating locked and unlocked position are reversed. |
| Dec 10, 2014 | Class II | Z-1037-2015 | Environmental control | Customer complaint indicating the color bands on the MIA16-G1 were not correct. |
The 5 latest of 11 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All HBC devicesHBC Motor, Drill, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · HBC
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HBC
Too few HBC 510(k)s in any year since 2007 to give a median.
Recalls per year · HBC
9in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HBC
635in 2025
MAUDE reports naming product code HBC, 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 | 5 |
| 2008 | 1 | — | 0 | 6 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 1 | 1 |
| 2011 | 0 | — | 9 | 1 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 2 | — | 0 | 10,670 |
| 2014 | 1 | — | 1 | 2,643 |
| 2015 | 0 | — | 0 | 1,953 |
| 2016 | 1 | — | 0 | 2,541 |
| 2017 | 2 | — | 0 | 2,079 |
| 2018 | 1 | — | 0 | 1,779 |
| 2019 | 1 | — | 0 | 1,703 |
| 2020 | 0 | — | 0 | 1,304 |
| 2021 | 1 | — | 0 | 946 |
| 2022 | 2 | — | 9 | 760 |
| 2023 | 0 | — | 0 | 663 |
| 2024 | 2 | — | 0 | 427 |
| 2025 | 0 | — | 0 | 635 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Anspach eG I High Speed Electric System is intended for cutting and shaping bone including spine and cranium.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133604 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133604: Anspach EG1 High Speed System, G1 Attachments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133604
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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