K213846 is an FDA 510(k) clearance for the Q2 Blood Administration Sets. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Quest Medical, Inc. (Allen, US). The FDA issued a Cleared decision on June 5, 2022, 177 days after receiving the submission on December 10, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K213846 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 10, 2021 |
| Decision Date | June 05, 2022 |
| Days to Decision | 177 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FPA — Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |