Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Electroscope, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
189 daysmedian FDA review time
191 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K000480 | ACTIVE ELECTRODE MONITORING SYSTEM | Electroscope, Inc. | 2000-05-02 | 78 | 3 |
| K972562 | BIPOLAR ELECTROSURGICAL PENCIL, STRAIGHT AND ANGLED | Electroscope, Inc. | 1998-01-16 | 191 | 0 |
| K973682 | BIPOLAR ARTHROSCOPIC PROBE, STRAIGHT, BIOPOLAR ARTHROSCOPIC | Electroscope, Inc. | 1997-12-18 | 83 | 0 |
| K913625 | ELECTROSCOPE MONITOR, EM-1 | Electroscope, Inc. | 1991-12-30 | 137 | 1 |
| K912780 | MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELD | Electroscope, Inc. | 1991-12-30 | 189 | 8 |
| K912781 | ELECTROSHIELD | Electroscope, Inc. | 1991-12-30 | 189 | 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