Submission Details
| 510(k) Number | K212445 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 05, 2021 |
| Decision Date | June 01, 2022 |
| Days to Decision | 300 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
freeflex+ Transfer Adapter
Jun 2022
Decision
300d
Days
Class 2
Risk
About This 510(k) Submission
K212445 is an FDA 510(k) clearance for the freeflex+ Transfer Adapter, a Set, I.v. Fluid Transfer (Class II — Special Controls, product code LHI), submitted by Fresenius Kabi AG (Bad Homburg, DE). The FDA issued a Cleared decision on June 1, 2022, 300 days after receiving the submission on August 5, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.
Device Classification
| Product Code | LHI — Set, I.v. Fluid Transfer |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5440 |
Manufacturer
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