Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)
FDA 510(k) clearance K251676 · decided 2025-09-16
Clearance details
- K-number
- K251676
- Device name
- Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)
- Applicant
- Microtek Medical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2025-05-30
- Decision date
- 2025-09-16
- Days to decision
- 109 days
- Clearance type
- Traditional
- Product code
- LHI
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Northfiled, IL, US
- Third-party review
- Yes
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ADRx™ Admixture Device (K252987) | Epic Medical Pte. , Ltd. | 2026-06-12 |
| Vial Adapter (K260301) | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2026-06-05 |
| Medline Bag Decanter (K250345) | Medline Industries, LP | 2025-10-24 |
| FlowArt® Vial Access Device Vented (K251715) | Asset Medikal | 2025-10-14 |
| HyHub™ and HyHub™ Duo Vial Access Devices (K243404) | Takeda Pharmaceuticals | 2025-07-18 |
| Arisure® Closed Male Luer with Spike Adapter (YM060) (K240761) | Yukon Medical, LLC | 2025-03-21 |
| Rio™ Drug Reconstitution Transfer Device (K243985) | Icu Medical, Inc. | 2025-01-22 |
| SmartSiteTM Vented Vial Access Device (K243486) | Yukon Medical, LLC | 2024-12-06 |
| nextaro® va, 15mm, 5µm (K241976) | Sfm Medical Devices GmbH | 2024-09-06 |
| Vent Vial Adapter (K233287) | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2024-07-26 |
| FlowArt Valve for Vial Access (K232987) | Asset Medikal Tasarim Sanayi VE Ticaret A.S. | 2024-06-26 |
| Vial2Bag Advanced® 20mm Admixture Device (K240940) | West Pharmaceutical Services, Inc. | 2024-05-03 |
Recalls involving this device
No recalls on record reference this clearance.