Dornoch Medical Systems: FDA clearances and approvals
Dornoch Medical Systems has 6 FDA 510(k) clearances (first 2008, latest 2019), across 1 product code in 1 review panel. Median 510(k) review time: 64 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 144 |
| 2014 | 1 | 99 |
| 2015 | 0 | — |
| 2016 | 1 | 113 |
| 2017 | 1 | 29 |
| 2018 | 0 | — |
| 2019 | 1 | 28 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Dornoch Medical Systems's cleared 510(k)s took a median 28 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 55 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | 6 | 6 |
Review panels
Most recent Dornoch Medical Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K190789 | IntelliCartTM System | JCX | 2019-04-24 | 28 |
| K172481 | IntelliCart System | JCX | 2017-09-14 | 29 |
| K162421 | IntelliCartTM System | JCX | 2016-12-21 | 113 |
| K133786 | DORNOCH DUO SUCTION CART WITH: DL2800 LID, CL500 LID, DORNOCH QUAD SUCTION CART WITH: DL2800 LID, CL500 LID | JCX | 2014-03-21 | 99 |
| K123188 | DORNOCH DUO SUCTION CART WITH DL2800 LID MODEL UL-DU2800, DORNOCH DUO SUCTION CART WITH CL500 LID MODEL UL-DU500, DORNOC | JCX | 2013-03-04 | 144 |
| K081047 | TRANSPOSAL ULTRA SYSTEMS | JCX | 2008-04-29 | 15 |
Recalls
openFDA lists no recalls under a recalling firm named Dornoch Medical Systems.
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 Dornoch Medical Systems have?
Dornoch Medical Systems has 6 FDA 510(k) clearances (first 2008, latest 2019), across 1 product code in 1 review panel.
How long does FDA take to clear Dornoch Medical Systems's 510(k)s?
The median time from FDA receipt to decision across Dornoch Medical Systems's cleared 510(k)s is 64 days.
What devices does Dornoch Medical Systems make?
Its most frequent FDA product codes are JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered, 6).
Has Dornoch Medical Systems had device recalls?
openFDA lists no recalls under a recalling firm name matching Dornoch Medical Systems. Related entities may recall under other names.
Next steps
- See all 6 Dornoch Medical Systems clearances with predicates and recalls
- Run predicate analysis for product code JCX, Dornoch Medical Systems'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.