Echo Ultrasound: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Echo Ultrasound” (first 1985, latest 1993), across 6 product codes in 5 review panels. Median 510(k) review time under this name: 96 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| DQC | Phonocardiograph | 1 | 1 |
| DXK | Echocardiograph | 1 | 1 |
| DYO | Band, Material, Orthodontic | 1 | 1 |
| GXX | Block, Test, Ultrasonic Scanner Calibration | 1 | 1 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
| JOT | Electrode, Gel, Electrosurgical | 1 | 1 |
Review panels
- Cardiovascular (2)
- Dental (1)
- Neurology (1)
- Radiology (1)
- General and Plastic Surgery (1)
Most recent Echo Ultrasound 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K924054 | PHONOCARDIOGRAPH | DQC | 1993-01-22 | 163 |
| K903414 | TRANSESOPHAGEAL PROBE HOLDER & DISINFECTING COLUMN | DXK | 1990-09-19 | 51 |
| K893225 | COUPLANT WARMING DEVICE | IYO | 1989-10-12 | 168 |
| K872519 | STERILIZED OMNI GEL | JOT | 1987-08-03 | 39 |
| K844120 | ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS | GXX | 1985-01-23 | 92 |
| K844034 | SONOCARE | DYO | 1985-01-23 | 99 |
Recalls
openFDA lists no recalls under a recalling firm named Echo Ultrasound.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Echo Laboratories, Inc. (4 510(k)s)
- Echo IQ, Ltd. (1 510(k)s)
- Echo Medical, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Echo Ultrasound?
FDA lists 6 510(k) clearances under the applicant name “Echo Ultrasound” (first 1985, latest 1993), across 6 product codes in 5 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Echo Ultrasound?
The median time from FDA receipt to decision across 510(k)s cleared under the name Echo Ultrasound is 96 days.
Which FDA product codes appear under Echo Ultrasound?
The most frequent FDA product codes under this applicant name are DQC (Phonocardiograph, 1); DXK (Echocardiograph, 1); DYO (Band, Material, Orthodontic, 1).
Next steps
- See all 6 Echo Ultrasound clearances with predicates and recalls
- Run predicate analysis for product code DQC, Echo Ultrasound's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.