Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lidco, Ltd. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
164 daysmedian FDA review time
925 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K163334 | LiDCOunity v2 Hemodynamic Monitor | Lidco, Ltd. | 2017-06-05 | 189 | 0 |
| K152935 | LiDCOunity Monitor | Lidco, Ltd. | 2016-03-17 | 164 | 0 |
| K131048 | LIDCO CNAP MODULE | Lidco, Ltd. | 2013-08-28 | 135 | 0 |
| K122247 | LIDCORAPID V2 MONITOR | Lidco, Ltd. | 2013-03-20 | 236 | 0 |
| K023960 | LIDCOPLUS HEMODYNAMIC MONITOR SYSTEM, MODEL HM 70 | Lidco, Ltd. | 2003-01-09 | 41 | 0 |
| K010049 | PULSECO HEMODYNAMIC MONITOR CM71 | Lidco, Ltd. | 2001-06-14 | 160 | 0 |
| K962918 | LIDCO SYSTEM | Lidco, Ltd. | 1999-01-08 | 925 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda