K220184 is an FDA 510(k) clearance for the Pump Alignment Syringe. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Jiangsu Caina Medical Co.,Ltd (Jiangyin, CN). The FDA issued a Cleared decision on July 21, 2022, 178 days after receiving the submission on January 24, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K220184 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 24, 2022 |
| Decision Date | July 21, 2022 |
| Days to Decision | 178 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMF — Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |