Intelligent Ultrasound Limited: FDA clearances and approvals
Intelligent Ultrasound Limited has 1 FDA 510(k) clearance (first 2023, latest 2023), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time: 25 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2023 | 1 | 25 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Intelligent Ultrasound Limited's cleared 510(k)s took a median 25 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 88 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QRG | Ultrasound Guided Nerve Block Assist | 2 | 1 |
Review panels
- Anesthesiology (2)
Most recent Intelligent Ultrasound Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232787 | ScanNav Anatomy Peripheral Nerve Block | QRG | 2023-10-06 | 25 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN220024 | De Novo | Ultrasound Guided Nerve Block Assist | 2022-10-18 |
Recalls
openFDA lists no recalls under a recalling firm named Intelligent Ultrasound Limited.
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 Intelligent Ultrasound Limited have?
Intelligent Ultrasound Limited has 1 FDA 510(k) clearance (first 2023, latest 2023), plus 1 De Novo decision, across 1 product code in 1 review panel.
How long does FDA take to clear Intelligent Ultrasound Limited's 510(k)s?
The median time from FDA receipt to decision across Intelligent Ultrasound Limited's cleared 510(k)s is 25 days.
What devices does Intelligent Ultrasound Limited make?
Its most frequent FDA product codes are QRG (Ultrasound Guided Nerve Block Assist, 2).
Has Intelligent Ultrasound Limited had device recalls?
openFDA lists no recalls under a recalling firm name matching Intelligent Ultrasound Limited. Related entities may recall under other names.
Next steps
- See all 1 Intelligent Ultrasound Limited clearances with predicates and recalls
- Run predicate analysis for product code QRG, Intelligent Ultrasound Limited'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.