Lidco, Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Lidco, Ltd.” (first 1999, latest 2017), across 1 product code in 1 review panel. Median 510(k) review time under this name: 164 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 | 2 | 186 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 164 |
| 2017 | 1 | 189 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Lidco, Ltd. took a median 189 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 169 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 7 | 7 |
Review panels
- Cardiovascular (7)
Most recent Lidco, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K163334 | LiDCOunity v2 Hemodynamic Monitor | DXG | 2017-06-05 | 189 |
| K152935 | LiDCOunity Monitor | DXG | 2016-03-17 | 164 |
| K131048 | LIDCO CNAP MODULE | DXG | 2013-08-28 | 135 |
| K122247 | LIDCORAPID V2 MONITOR | DXG | 2013-03-20 | 236 |
| K023960 | LIDCOPLUS HEMODYNAMIC MONITOR SYSTEM, MODEL HM 70 | DXG | 2003-01-09 | 41 |
| K010049 | PULSECO HEMODYNAMIC MONITOR CM71 | DXG | 2001-06-14 | 160 |
| K962918 | LIDCO SYSTEM | DXG | 1999-01-08 | 925 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2020-11-19.
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 Lidco, Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Lidco, Ltd.” (first 1999, latest 2017), across 1 product code 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 Lidco, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lidco, Ltd. is 164 days.
Which FDA product codes appear under Lidco, Ltd.?
The most frequent FDA product codes under this applicant name are DXG (Computer, Diagnostic, Pre-Programmed, Single-Function, 7).
Next steps
- See all 7 Lidco, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DXG, Lidco, Ltd.'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.