K253863 is an FDA 510(k) clearance for the GUARDIAN™ Quick Dip Residual Chlorine (5212). This device is classified as a Filter, Blood, Dialysis (Class II - Special Controls, product code FKJ).
Submitted by Serim Research (Elkhart, US). The FDA issued a Cleared decision on March 17, 2026, 104 days after receiving the submission on December 3, 2025.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K253863 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 2025 |
| Decision Date | March 17, 2026 |
| Days to Decision | 104 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FKJ — Filter, Blood, Dialysis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |