Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sodemsystems — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
70 daysmedian FDA review time
134 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K023070 | SODEM HIGH SPEED SYSTEM (PNEUMATIC) | Sodemsystems | 2003-01-28 | 134 | 0 |
| K023066 | DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED | Sodemsystems | 2002-11-25 | 70 | 0 |
| K012457 | SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY) | Sodemsystems | 2001-10-22 | 82 | 0 |
| K012453 | SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PL | Sodemsystems | 2001-10-22 | 82 | 0 |
| K012456 | SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT) | Sodemsystems | 2001-09-21 | 51 | 0 |
| K993851 | SODEM PERFORATOR DRIVE | Sodemsystems | 1999-12-27 | 45 | 0 |
| K994175 | MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL US | Sodemsystems | 1999-12-21 | 11 | 0 |
| K935567 | SODEM POWER SYSTEM | Sodemsystems | 1994-01-21 | 64 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda