510(k) · Cleared
ClearedSodem High Speed System (Pneumatic)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sodemsystems · ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Cleared on Jan 28, 2003 as substantially equivalent to K960630 (The Anspach Effort, Inc., 1996) and 1 other predicate after a 134-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Jan 28, 2003
- Review
- 134 days
- Class
- Class II
- Product code
- ERL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K960630 (1996). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK960630 Anspahc Speed ReducerThe Anspach Effort, Inc. · 1996 · Recalled
- This deviceK023070 Sodem High Speed System (Pneumatic)Sodemsystems · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K960630 | Anspahc Speed Reducer | The Anspach Effort, Inc. | 1996 | 4 |
| 0 (this device) | K023070 | Sodem High Speed System (Pneumatic) | Sodemsystems | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 ERL? 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 ERL device
- #1 K243280 Piezomed Pro (Piezomed Pro module M-PM100…score 12.0 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K960630 | Anspahc Speed ReducerSummary page 3…current submission K960630 /i ir965086 SlO(k) Number ,I,I,_,___ , .-----.---..… | 1996 |
| * | K965080 | Anspach Micromax System Our reading of the summary gave K965086, FDA’s number for Cygnus Electrosurgical Tip Cleaner (Madison Polymeric Engineering). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Anspach Black Max / Micromax System”. | 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?
- 2 of the 2 ancestors have a recall of any class.
How does its category compare?
All ERL devicesERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ERL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ERL
191in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ERL
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ERL
1,469in 2025
MAUDE reports naming product code ERL, 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 | 112 |
| 2008 | 6 | 181 | 0 | 60 |
| 2009 | 1 | — | 1 | 249 |
| 2010 | 0 | — | 0 | 444 |
| 2011 | 0 | — | 0 | 1,068 |
| 2012 | 2 | — | 0 | 1,379 |
| 2013 | 2 | — | 3 | 3,231 |
| 2014 | 1 | — | 0 | 1,975 |
| 2015 | 3 | 86 | 0 | 2,630 |
| 2016 | 4 | 180 | 0 | 1,455 |
| 2017 | 2 | — | 0 | 999 |
| 2018 | 1 | — | 0 | 1,380 |
| 2019 | 1 | — | 0 | 2,515 |
| 2020 | 1 | — | 5 | 2,369 |
| 2021 | 1 | — | 1 | 2,283 |
| 2022 | 3 | 191 | 0 | 1,574 |
| 2023 | 0 | — | 0 | 1,725 |
| 2024 | 1 | — | 0 | 1,588 |
| 2025 | 1 | — | 0 | 1,469 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Sodem High Speed System includes a pneumatic motor which allows the fixation of spindles, adapters and attachments, which operate with drills, burs and cutters for drilling, cutting and sculpting hard tissue and bone for different applications and surgeries.
The system is intended for use in Ear Nose and Throat (plastic reconstructive surgery) applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023070 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023070: Sodem High Speed System (Pneumatic).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023070
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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