Transfer-Aid(Tm)
FDA 510(k) K913985 · Healthtek, Inc.
510(k) numberK913985
Submission
- Device name
- Transfer-Aid(Tm)
- Applicant
- Healthtek, Inc.
Nevada City, CA, US - Received
- September 5, 1991
- Decision date
- March 18, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
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 |
|---|---|---|
| K923448 | Empty Solution Transfer Container W/ Detach LegKPE · Traditional | 07/28/1993SE |
| K913608 | SnapperKPE · Traditional | 11/29/1991SE |
| K881590 | Adfuse(Tm)FRN · Traditional | 05/23/1988SE |
| K874495 | Adcomp 4000 HP SystemLHI · Traditional | 02/16/1988SE |
| K873848 | Retrobulbar NeedleGDM · Traditional | 10/23/1987SE |
| K860610 | AdcompLHI · Traditional | 07/08/1986SE |
| K860372 | Fast Flow XX (Aqueous Solution Filter)FPB · Traditional | 05/30/1986SE |
| K854008 | StatlockLHI · Traditional | 11/13/1985SE |
Questions and answers
When was Transfer-Aid(Tm) cleared by the FDA?
Transfer-Aid(Tm) (K913985) received a 510(k) decision of Substantially Equivalent on March 18, 1992, 195 days after the submission was received.
What is the product code of K913985?
The FDA product code is LHI – Set, I.V. Fluid Transfer, a Class II (moderate risk) device regulated under 21 CFR 880.5440.