Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Icu Medical · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
255 daysmedian FDA review time
332 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232048 | Cogent™ Hemodynamic Monitoring System; Cogent™ HMS | Icu Medical | 2023-12-20 | 163 | 0 |
| K192154 | Rio Vial-to-Bag Drug Reconstitution Device | Icu Medical | 2020-04-20 | 255 | 0 |
| K190918 | SwabTip Male Disinfectant Cap | Icu Medical | 2020-03-06 | 332 | 0 |
| K190157 | Diana ChemoClave Transfer Set | Icu Medical | 2019-10-23 | 266 | 0 |
| K171346 | Sapphire Sets | Icu Medical | 2017-08-25 | 109 | 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