Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Echocath, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
273 daysmedian FDA review time
911 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K010482 | ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MOD | Echocath, Inc. | 2001-03-20 | 28 | 0 |
| K990642 | ECHOFLOW DOPPLER BLOOD VELOCITY METER | Echocath, Inc. | 1999-09-16 | 202 | 0 |
| K932436 | ECHOMARK INTRAUTERINE GUIDING CATHETER | Echocath, Inc. | 1995-11-16 | 911 | 0 |
| K933417 | ECHOMARK(R) ELECTROPHYSIOLOGY CATHETER | Echocath, Inc. | 1995-05-04 | 660 | 0 |
| K926351 | COLORMARK(TM) VISUALIZATION SYSTEM | Echocath, Inc. | 1993-09-16 | 273 | 0 |
| K922787 | ECHOMARK GUIDEWIRE WITH ULTRASONIC LOCALIZATION | Echocath, Inc. | 1993-01-06 | 211 | 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