Modified Sliding Reconstitution Device
510(k) K884626
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK884626 | Date22 Nov 1988 | 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- Withdrawn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 Modified Sliding Reconstitution Device is a medical device classified under the category of reconstitution aids, designed to facilitate the preparation of injectable medications by combining powdered drug formulations with liquid diluents. It ensures accurate and controlled mixing of sterile components, reducing the risk of contamination or dosage errors during reconstitution. This device is intended for use in hospital settings where intravenous or subcutaneous medications are prepared under aseptic conditions.
This device is supplied as a single-use item and is regulated under FDA 510(k) clearance (K884626) with a decision of Substantially Equivalent. It is intended for use in general hospital environments and adheres to sterile processing standards. The device is not MRI-compatible, and no specific size or storage requirements are detailed beyond standard sterile medical device handling. Authorized by Baxter Healthcare Corp, it is classified under product code LHI.
Other devices from Baxter Healthcare Corp
Questions
AI-generated answers, 1 Oct 2026
What is the Modified Sliding Reconstitution Device used for?
This device is designed to assist healthcare professionals in accurately mixing powdered drug formulations with liquid diluents to prepare injectable medications. It ensures controlled and sterile reconstitution, minimizing the risk of contamination or dosage errors, particularly for intravenous or subcutaneous medications prepared in hospital pharmacies or clinical areas.
Is the Modified Sliding Reconstitution Device intended for single-use or reuse?
The device is explicitly supplied as a single-use item. This design choice aligns with sterile processing standards to prevent cross-contamination between patients or preparations, ensuring safety and compliance with hospital aseptic protocols.
What regulatory clearance does the Modified Sliding Reconstitution Device hold?
The device holds FDA 510(k) clearance under the reference number K884626, with a decision classification of *Substantially Equivalent* to a predicate device. This clearance confirms its compliance with U.S. regulatory standards for reconstitution aids in general hospital environments.
Are there specific storage requirements for this device beyond standard sterile handling?
No detailed storage specifications beyond standard sterile medical device handling are provided. It is recommended to follow general guidelines for maintaining sterility, such as protecting from moisture, extreme temperatures, and physical damage, until immediate use.
Can the Modified Sliding Reconstitution Device be used in MRI environments?
The device is explicitly noted as *not MRI-compatible*. This means it should not be used or stored in areas where MRI scans are performed, as exposure to magnetic fields could pose risks to the device or interfere with imaging.