510(k) · Cleared
ClearedWireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)
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 May 19, 2022 as substantially equivalent to K133604 (The Anspach Effort, Inc., 2014) after a 91-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- May 19, 2022
- Review
- 91 days
- Class
- Class II
- Product code
- HBC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K011444 (2001). No later device cites it as a predicate yet.
- Root · 2 generations backK011444 Anspach Emax Drill SystemThe Anspach Effort, Inc. · 2001 · Recalled
- 1 generation backK133604 Anspach EG1 High Speed System, G1 AttachmentsThe Anspach Effort, Inc. · 2014 · Recalled
- This deviceK220485 Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless…The Anspach Effort, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011444 | Anspach Emax Drill System | The Anspach Effort, Inc. | 2001 | 70 |
| −1 | K133604 | Anspach EG1 High Speed System, G1 Attachments | The Anspach Effort, Inc. | 2014 | 11 |
| 0 (this device) | K220485 | Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control… | The Anspach Effort, Inc. | 2022 | — |
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 |
|---|---|---|---|
| * | K133604 | Anspach EG1 High Speed System, G1 AttachmentsSummary page 4…evice Manufacturer: The Anspach Effort, Inc. Predicate Device Common Name: eG1 High Speed System Predicate Device Premarket Notification # K133604 882.4360 – Electrical cranial drill motor Predicate Device Regulation & Name:… | 2014 |
| † | K203739 | ELAN 4 Electro Motor System | 2021 |
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 21 years and passes through 1 company; a new generation was cleared every 12.4 years on median.
- 2 of the 2 ancestors have a recall of any class.
How does its category compare?
All HBC devicesHBC Motor, Drill, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 eG1 High Speed System is indicated for cutting and shaping bone including spine and cranium.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220485 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220485: Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220485
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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