# K023070: Sodem High Speed System (Pneumatic)

- Pathway: 510(k) (Traditional)
- Applicant: Sodemsystems
- Decided: Jan 28, 2003 after 134 days
- Product code: ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece)
- Device class: 2
- Regulation: 21 CFR 874.4250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K960630 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960630: Anspahc Speed Reducer, The Anspach Effort, Inc. (1996) Summary page 3.
- K965080: Anspach Micromax System, The Anspach Effort, Inc. (1997). 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”.

## Indications for use
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.

Source page: https://510kreport.com/device/K023070
Methodology: https://510kreport.com/methodology