Automix Compounder Y - Adaptor Set
by Stedim, Inc.
510(k) K890205
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK890205 | Date27 Oct 1989 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LHI
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5440
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Automix Compounder Y - Adaptor Set is a sterile, single-use accessory designed for use with the Automix Compounder Y system. This device facilitates the preparation of intravenous admixtures by enabling the connection of various infusion components, including bags and spikes, to the compounder’s mixing chamber. It ensures compatibility between the compounder’s internal tubing and external infusion lines, supporting aseptic compounding procedures in hospital pharmacies and clinical settings. The adaptor set is categorized under product code LHI, reflecting its role in intravenous therapy preparation.
This adaptor set is supplied as a sterile, single-use item intended for use in controlled environments such as hospital pharmacies or sterile compounding areas. It is not intended for MRI use and must be handled according to standard aseptic techniques to prevent contamination. The set includes components sized for the Automix Compounder Y system, with no additional sizing variations specified beyond the standard 48X1 configuration. Authorized for use in the United States under FDA 510(k) clearance (K890205), the device adheres to regulatory standards for intravenous compounding accessories and is intended exclusively for its specified application in automated admixture preparation.
Other devices from Stedim, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Automix Compounder Y Adaptor Set used for?
The Automix Compounder Y Adaptor Set is designed to connect infusion components—such as bags and spikes—to the Automix Compounder Y’s mixing chamber. It bridges the internal tubing of the compounder with external infusion lines, ensuring compatibility during the aseptic preparation of intravenous admixtures in hospital pharmacies or sterile compounding areas. This accessory streamlines the process of mixing medications while maintaining sterility, which is critical for patient safety in clinical settings.
Is the Automix Compounder Y Adaptor Set sterile and single-use?
Yes, the adaptor set is supplied as a sterile, single-use item. Sterility is essential for preventing contamination during intravenous compounding, and its single-use nature aligns with best practices for aseptic procedures. Reusing this accessory could compromise sterility and patient safety, so it must be discarded after one use.
What sizes or configurations are available for the Automix Compounder Y Adaptor Set?
The adaptor set is supplied in a standard configuration labeled 48X1, which is specifically sized for compatibility with the Automix Compounder Y system. No additional sizing variations are specified beyond this single configuration, ensuring it fits seamlessly with the compounder’s tubing and infusion lines. Always verify the adaptor’s compatibility with your specific Automix model before use.
How should the Automix Compounder Y Adaptor Set be stored?
The adaptor set should be stored in its original, sealed packaging until ready for use. It must remain in a clean, dry environment protected from physical damage, moisture, or contamination. Since it is single-use and sterile, avoid exposing it to direct light or extreme temperatures, which could degrade its integrity. Always follow manufacturer guidelines for sterile storage to maintain its performance and safety.
Can the Automix Compounder Y Adaptor Set be used with MRI equipment?
No, the adaptor set is explicitly not intended for MRI use. Its materials and design are optimized solely for aseptic compounding in hospital pharmacies or sterile preparation areas. Using it in an MRI environment could pose risks to both the device and the patient, as MRI-compatible materials are not specified or tested for this application.