Echocath, Inc.: FDA clearances and approvals
Echocath, Inc. has 6 FDA 510(k) clearances (first 1993, latest 2001), across 5 product codes in 3 review panels. Median 510(k) review time: 242 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 |
|---|---|---|---|
| JOP | Transducer, Ultrasonic | 2 | 2 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 1 | 1 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 1 | 1 |
| MOV | Catheters, Salpingography | 1 | 1 |
Review panels
- Cardiovascular (4)
- Obstetrics and Gynecology (1)
- Radiology (1)
Most recent Echocath, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K010482 | ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1 | JOP | 2001-03-20 | 28 |
| K990642 | ECHOFLOW DOPPLER BLOOD VELOCITY METER | JOP | 1999-09-16 | 202 |
| K932436 | ECHOMARK INTRAUTERINE GUIDING CATHETER | MOV | 1995-11-16 | 911 |
| K933417 | ECHOMARK(R) ELECTROPHYSIOLOGY CATHETER | DRF | 1995-05-04 | 660 |
| K926351 | COLORMARK(TM) VISUALIZATION SYSTEM | IYN | 1993-09-16 | 273 |
| K922787 | ECHOMARK GUIDEWIRE WITH ULTRASONIC LOCALIZATION | DQX | 1993-01-06 | 211 |
Recalls
openFDA lists no recalls under a recalling firm named Echocath, Inc..
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 Echocath, Inc. have?
Echocath, Inc. has 6 FDA 510(k) clearances (first 1993, latest 2001), across 5 product codes in 3 review panels.
How long does FDA take to clear Echocath, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Echocath, Inc.'s cleared 510(k)s is 242 days.
What devices does Echocath, Inc. make?
Its most frequent FDA product codes are JOP (Transducer, Ultrasonic, 2); DQX (Wire, Guide, Catheter, 1); DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording, 1).
Has Echocath, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Echocath, Inc. Related entities may recall under other names.
Next steps
- See all 6 Echocath, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JOP, Echocath, Inc.'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.