Adr Ultrasound: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Adr Ultrasound” (first 1980, latest 1984), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 52 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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 4 | 4 |
| ITX | Transducer, Ultrasonic, Diagnostic | 2 | 2 |
Plus 1 more product codes.
Review panels
- Radiology (6)
Most recent Adr Ultrasound 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K840408 | LINEAR ARRAY TRANSDUCER OR SCANHEAD | IYO | 1984-04-25 | 85 |
| K834141 | ULTRASOUND SCAN HEAD 3.5 MHZ | IYO | 1984-04-20 | 121 |
| K833224 | BIFOCAL 3.0MHZ | ITX | 1983-11-29 | 84 |
| K828053 | ADR ULTRASOUND 5.5 MHZ SHORT FOCUS TRANSDUCER | — | 1982-09-29 | 29 |
| K828051 | ADR ULTRASOUND MODEL 4000 SC OR 4000 S/LC | — | 1982-09-29 | 29 |
| K828050 | ADR ULTRASOUND MODEL 4000 L | — | 1982-09-29 | 29 |
| K828049 | ADR ULTRASOUND MC2 LARGE CART | — | 1982-09-29 | 29 |
| K813543 | ADR ULTRASOUND MODELS 4000S & 4000S/L | IYO | 1982-02-24 | 65 |
| K812301 | VARIABLE FOCUS 3.5 MHZ TRANSDUCER | ITX | 1981-11-16 | 94 |
| K792446 | ADR REAL-TIME SECTOR SCANNER | IYO | 1980-01-09 | 40 |
Recalls
openFDA lists no recalls under a recalling firm named Adr 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Adr Ultrasound?
FDA lists 10 510(k) clearances under the applicant name “Adr Ultrasound” (first 1980, latest 1984), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Adr Ultrasound?
The median time from FDA receipt to decision across 510(k)s cleared under the name Adr Ultrasound is 52 days.
Which FDA product codes appear under Adr Ultrasound?
The most frequent FDA product codes under this applicant name are IYO (System, Imaging, Pulsed Echo, Ultrasonic, 4); ITX (Transducer, Ultrasonic, Diagnostic, 2).
Next steps
- See all 10 Adr Ultrasound clearances with predicates and recalls
- Run predicate analysis for product code IYO, Adr 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.