Add-A-Vial
FDA 510(k) K904855 · Kendall Mcgaw Laboratories, Inc.
510(k) numberK904855
Submission
- Device name
- Add-A-Vial
- Applicant
- Kendall Mcgaw Laboratories, Inc.
Irvine, CA, US - Received
- October 29, 1990
- Decision date
- November 19, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LHI – Set, I.V. Fluid Transfer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
Other 510(k)s with product code LHI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252987 | ADRx Admixture DeviceLHI · Traditional | Epic Medical Pte. , Ltd. | 06/12/2026SE |
| K260301 | Vial AdapterLHI · Traditional | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 06/05/2026SE |
| K250345 | Medline Bag DecanterLHI · Traditional | Medline Industries, LP | 10/24/2025SE |
| K251715 | FlowArt® Vial Access Device VentedLHI · Traditional | Asset Medikal | 10/14/2025SE |
| K251676 | Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II…LHI · Traditional | Microtek Medical, LLC | 09/16/2025SE |
| 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 |
|---|---|---|
| K905611 | Microrate Plus Intelligent PumpFRN · Traditional | 03/01/1991SE |
| K905610 | Microrate Intelligent PumpFRN · Traditional | 03/01/1991SE |
| K904518 | Volumetric Infusion PumpFRN · Traditional | 10/17/1990SE |
| K903809 | Protected Needle with or Without IV SetFPA · Traditional | 10/03/1990SE |
| K901065 | Infusion PumpFRN · Traditional | 08/21/1990SE |
| K900865 | Add-A-Vial II Binary ConnectorLHI · Traditional | 07/11/1990SE |
| K896292 | 1.2 Micron Filter with IV SetFPB · Traditional | 12/08/1989SE |
| K895109 | Secondary IV Set with Protected NeedleFPA · Traditional | 09/27/1989SE |
| K882159 | 522 Intelligent PumpFRN · Traditional | 08/24/1988SE |
| K874467 | Set, Administration IntravascularFPA · Traditional | 01/06/1988SE |
Questions and answers
When was Add-A-Vial cleared by the FDA?
Add-A-Vial (K904855) received a 510(k) decision of Substantially Equivalent on November 19, 1990, 21 days after the submission was received.
What is the product code of K904855?
The FDA product code is LHI – Set, I.V. Fluid Transfer, a Class II (moderate risk) device regulated under 21 CFR 880.5440.