510(k) · Cleared
Recalled · Class II · 2016Anspahc Speed Reducer
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 Nov 19, 1996 after a 284-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it. It has been recalled 4 times.
- Decided
- Nov 19, 1996
- Review
- 284 days
- Class
- Class II
- Product code
- HBB
- Recalls
- 4
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK960630 Anspahc Speed ReducerThe Anspach Effort, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK023070 Sodem High Speed System (Pneumatic)Sodemsystems · 2003
Most influential descendants
Showing 1 of 1 · See all- K023070Sodem High Speed System (Pneumatic)Sodemsystems · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960630 | Anspahc Speed Reducer | The Anspach Effort, Inc. | 1996 | — |
| +1 | K023070 | Sodem High Speed System (Pneumatic) | Sodemsystems | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
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 |
|---|---|---|---|
| K023070 | Sodem High Speed System (Pneumatic) | 2003 | 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-1993-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-1992-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Nov 28, 2012 | Class II | Z-1900-2014 | 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-1901-2014 | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K023070 (Sodemsystems, 2003) has gone furthest, with 0 descendants of its own.
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 | — |
https://510kreport.com/device/K960630 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960630: Anspahc Speed Reducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960630
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026