Safeline I.V. Bag Access Device
FDA 510(k) K955594 · Mcgaw, Inc.
510(k) numberK955594
Submission
- Device name
- Safeline I.V. Bag Access Device
- Applicant
- Mcgaw, Inc.
Irvine, CA, US - Received
- December 8, 1995
- Decision date
- March 6, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LHI – Set, I.V. Fluid Transfer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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| K250345 | Medline Bag DecanterLHI · Traditional | Medline Industries, LP | 10/24/2025SE |
| K251715 | FlowArt® Vial Access Device VentedLHI · Traditional | Asset Medikal | 10/14/2025SE |
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| K243404 | HyHub and HyHub Duo Vial Access DevicesLHI · Traditional | Takeda Pharmaceuticals | 07/18/2025SE |
| K240761 | Arisure® Closed Male Luer with Spike Adapter (YM060)LHI · Traditional | Yukon Medical, LLC | 03/21/2025SE |
| K243985 | Rio Drug Reconstitution Transfer DeviceLHI · Traditional | Icu Medical, Inc. | 01/22/2025SE |
| K243486 | SmartSiteTM Vented Vial Access DeviceLHI · Traditional | Yukon Medical, LLC | 12/06/2024SE |
| K241976 | nextaro® va, 15mm, 5µmLHI · Special | Sfm Medical Devices GmbH | 09/06/2024SE |
More from Sfm Medical Devices GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K972678 | Millennium CRT Infusion Pump and Millennium CRT Infusion Pump Administration SetsFRN · Traditional | 10/07/1997SE |
| K955595 | Safeline Multidose Vial AdapterLHI · Traditional | 03/06/1996SE |
| K941244 | Safeline System Turn Lock CannulaFPA · Traditional | 11/29/1994SE |
| K932165 | Intravascular Administration SetFPA · Traditional | 04/13/1994SE |
| K931377 | Safeline System IV Administration Sets & ComponentFPA · Traditional | 03/07/1994SE |
| K932856 | Irrigation Access CapFPA · Traditional | 01/26/1994SE |
| K922637 | Horizon Pump Y-Type Blood SetFPA · Traditional | 06/04/1993SE |
| K921860 | Modification to IV SpikeFPA · Traditional | 07/30/1992SE |
| K913661 | Modified Volumetric Infusion PumpFRN · Traditional | 12/18/1991SE |
| K913056 | Volumetric Infusion Pump, ModificationFRN · Traditional | 09/06/1991SE |
Questions and answers
When was Safeline I.V. Bag Access Device cleared by the FDA?
Safeline I.V. Bag Access Device (K955594) received a 510(k) decision of Substantially Equivalent on March 6, 1996, 89 days after the submission was received.
What is the product code of K955594?
The FDA product code is LHI – Set, I.V. Fluid Transfer, a Class II (moderate risk) device regulated under 21 CFR 880.5440.