Sodemsystems: FDA clearances and approvals
Sodemsystems has 8 FDA 510(k) clearances (first 1994, latest 2003), across 4 product codes in 3 review panels. Median 510(k) review time: 67 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HBB | Motor, Drill, Pneumatic | 3 | 3 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 2 | 2 |
| HBC | Motor, Drill, Electric | 2 | 2 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | 1 | 1 |
Review panels
- Neurology (5)
- Ear, Nose and Throat (2)
- Orthopedic (1)
Most recent Sodemsystems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K023070 | SODEM HIGH SPEED SYSTEM (PNEUMATIC) | ERL | 2003-01-28 | 134 |
| K023066 | DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC) | HBB | 2002-11-25 | 70 |
| K012457 | SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY) | HBC | 2001-10-22 | 82 |
| K012453 | SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY) | HBC | 2001-10-22 | 82 |
| K012456 | SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT) | ERL | 2001-09-21 | 51 |
| K993851 | SODEM PERFORATOR DRIVE | HBB | 1999-12-27 | 45 |
| K994175 | MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE | HBB | 1999-12-21 | 11 |
| K935567 | SODEM POWER SYSTEM | HWE | 1994-01-21 | 64 |
Recalls
openFDA lists no recalls under a recalling firm named Sodemsystems.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Sodemsystems have?
Sodemsystems has 8 FDA 510(k) clearances (first 1994, latest 2003), across 4 product codes in 3 review panels.
How long does FDA take to clear Sodemsystems's 510(k)s?
The median time from FDA receipt to decision across Sodemsystems's cleared 510(k)s is 67 days.
What devices does Sodemsystems make?
Its most frequent FDA product codes are HBB (Motor, Drill, Pneumatic, 3); ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece, 2); HBC (Motor, Drill, Electric, 2).
Has Sodemsystems had device recalls?
openFDA lists no recalls under a recalling firm name matching Sodemsystems. Related entities may recall under other names.
Next steps
- See all 8 Sodemsystems clearances with predicates and recalls
- Run predicate analysis for product code HBB, Sodemsystems's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.