K202732 is an FDA 510(k) clearance for the SOL-CARE IV Bag Safety Connector. This device is classified as a Set, I.v. Fluid Transfer (Class II - Special Controls, product code LHI).
Submitted by Sol-Millennium Medical Group (Suwanee, US). The FDA issued a Cleared decision on November 3, 2021, 411 days after receiving the submission on September 18, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K202732 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 18, 2020 |
| Decision Date | November 03, 2021 |
| Days to Decision | 411 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LHI - Set, I.v. Fluid Transfer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |