Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
The Electrode Store, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
240 daysmedian FDA review time
1099 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K083758 | SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE | The Electrode Store, Inc. | 2009-08-14 | 240 | 0 |
| K022197 | SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHY | The Electrode Store, Inc. | 2002-08-13 | 39 | 0 |
| K020910 | SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODEL | The Electrode Store, Inc. | 2002-07-19 | 121 | 0 |
| K020445 | THE ELECTRODE STORE SURFACE (CUTANEOUS) ELECTRODE FOR EMG | The Electrode Store, Inc. | 2002-05-10 | 88 | 0 |
| K926094 | PROTECTRODE SYSTEM | The Electrode Store, Inc. | 1995-12-06 | 1099 | 0 |
| K932691 | PROTECTRODE SYSTEMS CONCENTRIC | The Electrode Store, Inc. | 1995-11-16 | 897 | 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