Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Electrocaine Medical System · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
78 daysmedian FDA review time
248 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K924413 | FLOWSCAN | Electrocaine Medical System | 1993-05-06 | 248 | 0 |
| K926336 | AUDIOSCAN | Electrocaine Medical System | 1993-03-04 | 78 | 0 |
| K844638 | ELECTROCAINE MODEL SR-IV | Electrocaine Medical System | 1985-01-08 | 41 | 0 |
| K830992 | XCEL MODEL XE-1 | Electrocaine Medical System | 1983-08-12 | 136 | 0 |
| K800317 | DAVOL EMS ADAPTER, CAT. NO. 13-7664 | Electrocaine Medical System | 1980-03-12 | 29 | 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