Vitalmix (Set & Bag)
FDA 510(k) K902482 · Pacific Device, Inc.
510(k) numberK902482
Submission
- Device name
- Vitalmix (Set & Bag)
- Applicant
- Pacific Device, Inc.
San Diego, CA, US - Received
- June 4, 1990
- Decision date
- July 2, 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
Questions and answers
When was Vitalmix (Set & Bag) cleared by the FDA?
Vitalmix (Set & Bag) (K902482) received a 510(k) decision of Substantially Equivalent on July 2, 1990, 28 days after the submission was received.
What is the product code of K902482?
The FDA product code is LHI – Set, I.V. Fluid Transfer, a Class II (moderate risk) device regulated under 21 CFR 880.5440.