510(k) · Cleared
Recalled · Class II · 2016Anspach Mri Safe Surgical Drill System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Anspach Effort, Inc. · HBB Motor, Drill, Pneumatic
Cleared on Apr 15, 2004 after a 79-day review. The FDA summary names its predicate without a number. It has been recalled 7 times.
- Decided
- Apr 15, 2004
- Review
- 79 days
- Class
- Class II
- Product code
- HBB
- Recalls
- 7
- Predicates
- 0
The FDA summary names its predicate without a number.
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 HBB? 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 HBB device
- #1 K253772 Velocity Alpha MR High Speed Surgical Drill…score 11.0 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | — | MicroMax Named without a submission number | |
| * | — | original 65K Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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-1942-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-1998-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-1943-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-1997-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-1996-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Nov 28, 2012 | Class II | Z-1906-2014 | Process design | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements. |
| Nov 28, 2012 | Class II | Z-1907-2014 | Process design | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All HBB devicesHBB Motor, Drill, Pneumatic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HBB
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · HBB
Too few HBB 510(k)s in any year since 2007 to give a median.
Recalls per year · HBB
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HBB
1,016in 2025
MAUDE reports naming product code HBB, 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 | 1 | — | 1 | 82 |
| 2008 | 0 | — | 1 | 176 |
| 2009 | 1 | — | 1 | 196 |
| 2010 | 2 | — | 0 | 183 |
| 2011 | 0 | — | 0 | 399 |
| 2012 | 0 | — | 0 | 379 |
| 2013 | 0 | — | 1 | 685 |
| 2014 | 0 | — | 0 | 562 |
| 2015 | 1 | — | 1 | 440 |
| 2016 | 0 | — | 0 | 273 |
| 2017 | 1 | — | 1 | 203 |
| 2018 | 1 | — | 0 | 295 |
| 2019 | 0 | — | 0 | 284 |
| 2020 | 0 | — | 0 | 263 |
| 2021 | 0 | — | 0 | 260 |
| 2022 | 0 | — | 0 | 172 |
| 2023 | 0 | — | 0 | 180 |
| 2024 | 0 | — | 0 | 759 |
| 2025 | 0 | — | 2 | 1,016 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The MRI Safe Surgical Drill System (including pneumatic drill motor, foot control, nosepiece attachments and cutters), is indicated for intra-operative (non-imaging) use within a Magnetic Resonance Imaging (MRI) environment rated at 0.5 Tesla or less, for surgical cutting, shaping and removal of bone, including bones of the skull and spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040186 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040186: Anspach Mri Safe Surgical Drill System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040186
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026