510(k) · Cleared
ClearedSodem Perforator Drive
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sodemsystems · HBB Motor, Drill, Pneumatic
Cleared on Dec 27, 1999 as substantially equivalent to K935567 (Sodemsystems, 1994) and 1 other predicate after a 45-day review. Its family tree reaches back 2 generations to 1983.
- Decided
- Dec 27, 1999
- Review
- 45 days
- Class
- Class II
- Product code
- HBB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K831756 (1983). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K831756 | Anspach 65,000 | The Anspach Effort, Inc. | 1983 | 1 |
| −1 | K954717 | Sodem High Speed System for Neurosurgery & Median Sternotomy | Sodem Diffusion SA | 1997 | — |
| 0 (this device) | K993851 | Sodem Perforator Drive | Sodemsystems | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 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 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 |
|---|---|---|---|
| * | K935567 | Sodem Power SystemSummary page 1…ial Drill Motor Common / Usual Name : Surgical drill 3 PREDICATE DEVICES The Sodem Perforator Drive claims equivalence to the following systems: ¢ Sodem Power System ( K935567) ¢ Sodem High Speed System ( K954717) SODEM PERFORATOR DRIVE 510(K) 09/11/1999 Page 1 £ 97 3¢/ 510(k) SUMMARY P… | 1994 |
| * | K954717 | Sodem High Speed System for Neurosurgery & Median SternotomySummary page 1…Surgical drill 3 PREDICATE DEVICES The Sodem Perforator Drive claims equivalence to the following systems: ¢ Sodem Power System ( K935567) ¢ Sodem High Speed System ( K954717) SODEM PERFORATOR DRIVE 510(K) 09/11/1999 Page 1 £ 97 3¢/ 510(k) SUMMARY PRt FOR SODEM PERFORATOR DRIVE 4 DEVI… | 1997 |
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 16 years and passes through 3 companies; a new generation was cleared every 13.3 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 2 other devices also cite its predicate K935567.
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 Sodem Perforator Drive is intended for use in nenrosirgery.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993851 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993851: Sodem Perforator Drive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993851
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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