Rio Vial-to-Bag Drug Reconstitution Device
FDA 510(k) clearance K192154 · decided 2020-04-20
Clearance details
- K-number
- K192154
- Device name
- Rio Vial-to-Bag Drug Reconstitution Device
- Applicant
- Icu Medical
- Decision
- Substantially Equivalent
- Date received
- 2019-08-09
- Decision date
- 2020-04-20
- Days to decision
- 255 days
- Clearance type
- Traditional
- Product code
- LHI
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- San Clemente, CA, US
- Third-party review
- No
- Expedited review
- No
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|---|
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| Vial Adapter (K260301) | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2026-06-05 |
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| 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) (K251676) | Microtek Medical, LLC | 2025-09-16 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.