Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Q Core Medical , Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
284 daysmedian FDA review time
412 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K192860 | Sapphire Infusion Pump, Sapphire administration sets | Q Core Medical , Ltd. | 2020-11-19 | 412 | 1 |
| K161667 | Sapphire Infusion Pump | Q Core Medical , Ltd. | 2017-03-27 | 284 | 0 |
| K141389 | SAPPHIRE INFUSION PUMP | Q Core Medical , Ltd. | 2014-12-11 | 198 | 0 |
| K141834 | SAPPHIRE ADMINISTRATION SET | Q Core Medical , Ltd. | 2014-08-05 | 29 | 0 |
| K123049 | SAPPHIRE INFUSION PUMP | Q Core Medical , Ltd. | 2013-10-17 | 384 | 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