Biosound, Inc.: FDA clearances and approvals
Biosound, Inc. has 39 FDA 510(k) clearances (first 1983, latest 1997), across 14 product codes in 3 review panels. Median 510(k) review time: 190 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 |
|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | 13 | 13 |
| DXK | Echocardiograph | 5 | 5 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 4 | 4 |
| DPS | Electrocardiograph | 3 | 3 |
| GWQ | Full-Montage Standard Electroencephalograph | 3 | 3 |
| JOP | Transducer, Ultrasonic | 2 | 2 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 2 | 2 |
| DPW | Flowmeter, Blood, Cardiovascular | 1 | 1 |
| GWF | Stimulator, Electrical, Evoked Response | 1 | 1 |
| IKN | Electromyograph, Diagnostic | 1 | 1 |
Plus 4 more product codes.
Review panels
- Radiology (21)
- Cardiovascular (11)
- Neurology (6)
Most recent Biosound, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K971700 | BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCER | ITX | 1997-07-09 | 62 |
| K963936 | ACCESSPOINT, MED E-MAIL, DICOM READER | LMB | 1997-03-31 | 181 |
| K963262 | ARTOSCAN M | LNH | 1997-03-28 | 220 |
| K963662 | GALILEO EVOKED POTENTIALRE | GWF | 1997-02-26 | 166 |
| K953716 | INTRACAVITY TRANSDUCERS | ITX | 1996-04-17 | 252 |
| K953530 | DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A | IYO | 1996-04-08 | 256 |
| K953819 | DIAGNOSTIC ULTRASOUND TRANDUCER | ITX | 1996-03-01 | 199 |
| K953759 | DIAGNOSTIC ULTRASOUND TRANSDUCER | ITX | 1996-03-01 | 203 |
| K955458 | ULTRASOUND PROBE BIOPSY ACCESSORIES | ITX | 1996-02-12 | 75 |
| K953579 | TEE PROBE | ITX | 1996-02-02 | 185 |
29 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Biosound, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Biosound, Inc.'s product codes (a text match, not an official crosswalk):
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
- C8900 — Magnetic resonance angiography with contrast, abdomen (via LNH)
Frequently asked questions
How many FDA 510(k) clearances does Biosound, Inc. have?
Biosound, Inc. has 39 FDA 510(k) clearances (first 1983, latest 1997), across 14 product codes in 3 review panels.
How long does FDA take to clear Biosound, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Biosound, Inc.'s cleared 510(k)s is 190 days.
What devices does Biosound, Inc. make?
Its most frequent FDA product codes are ITX (Transducer, Ultrasonic, Diagnostic, 13); DXK (Echocardiograph, 5); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 4).
Has Biosound, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Biosound, Inc. Related entities may recall under other names.
Next steps
- See all 39 Biosound, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ITX, Biosound, 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.