Submission Details
| 510(k) Number | K250345 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 06, 2025 |
| Decision Date | October 24, 2025 |
| Days to Decision | 260 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
Medline Bag Decanter
Oct 2025
Decision
260d
Days
Class 2
Risk
About This 510(k) Submission
K250345 is an FDA 510(k) clearance for the Medline Bag Decanter, a Set, I.v. Fluid Transfer (Class II — Special Controls, product code LHI), submitted by Medline Industries, LP (Nortfield, US). The FDA issued a Cleared decision on October 24, 2025, 260 days after receiving the submission on February 6, 2025. 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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