Lidco Ltd
LONDON England, GB
LIDCO LTD. appears in FDA device records in LONDON England, GB. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Lidco Ltd between 2001 and 2017. The busiest year on record is 2013, with 2. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2003 | 1 |
| 2013 | 2 |
| 2016 | 1 |
| 2017 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K163334 | LiDCOunity v2 Hemodynamic Monitor | DXG | Substantially Equivalent | |
| K152935 | LiDCOunity Monitor | DXG | Substantially Equivalent | |
| K131048 | LIDCO CNAP MODULE | DXG | Substantially Equivalent | |
| K122247 | LIDCORAPID V2 MONITOR | DXG | Substantially Equivalent | |
| K023960 | LIDCOPLUS HEMODYNAMIC MONITOR SYSTEM, MODEL HM 70 | DXG | Substantially Equivalent | |
| K010049 | PULSECO HEMODYNAMIC MONITOR CM71 | DXG | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9617127 | 3001139253 | LIDCO LTD. | Unit D4, LONDON England N17 0QJ GB | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0756-2021 | CM 50-001-01 Injectate Kit, accessory device to LiDCOunity v2 Monitor - Product Usage: intended to administer lithium dilution indicator (tube administrative set). | The expiration date on labeling is incorrect. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain