Identifiers
- 510(k) Number
- K994230 FDA 510(k)
- FDA Product Code
- FMF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5860 FDA 510(k)
- Regulation Number
- 880.5860 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The UltiCare Disposable Syringe is a single-use, sterile medical device classified as a disposable syringe under the FDA’s product code FMF. Designed for general hospital use, it is intended for the accurate administration of liquids, including medications, vaccines, or fluids, in clinical settings. Constructed for precision and reliability, it adheres to standards for aseptic processing and patient safety. The device is engineered to minimize contamination risk and ensure ease of use in procedural environments.
Supplied as a sterile, single-use item, the UltiCare Disposable Syringe is intended for one-time clinical application and subsequent disposal. It is regulated under the FDA’s 510(k) clearance pathway, classified as a Class II device with Traditional review, and bears the product code FMF. Manufacturing adheres to ISO 13485:2016 quality management system standards, ensuring compliance with regulatory requirements for medical devices. No MRI safety information is specified, and sizes such as 1.5 mL are available as indicated in product listings.
Frequently asked questions
What is the UltiCare Disposable Syringe designed for?
The UltiCare Disposable Syringe is specifically engineered for the accurate administration of liquids in clinical environments, including medications, vaccines, or fluids. Its design prioritizes precision and reliability to ensure safe and effective use during procedures, while also minimizing contamination risks for patient safety.
Is the UltiCare Disposable Syringe reusable or single-use?
The UltiCare Disposable Syringe is intended for single-use only. It is supplied sterile and must be discarded after one clinical application to maintain aseptic conditions and prevent cross-contamination, aligning with best practices for disposable medical devices.
What sizes are available for the UltiCare Disposable Syringe?
The UltiCare Disposable Syringe is available in at least a 1.5 mL size, as referenced in product listings. Additional sizes may be offered, but this is the confirmed volume specified in available documentation.
How is sterility maintained in the UltiCare Disposable Syringe?
Sterility is maintained through aseptic processing standards during manufacturing, ensuring the syringe remains uncontaminated until use. The device is packaged sterile and intended for immediate single-use to preserve its sterile integrity.
What regulatory pathway does the UltiCare Disposable Syringe follow?
The UltiCare Disposable Syringe is classified as a Class II medical device under the FDA’s 510(k) clearance pathway, with a Traditional review process. It holds product code FMF and was determined to be substantially equivalent to predicate devices, ensuring compliance with U.S. regulatory standards for disposable syringes.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: UltiCare - UltiMed, Inc, UltiMed, Inc. - UltiGuard Safe Pack | UltiMed, Inc, K994230 FDA 510(k) - ULTICARE DISPOSABLE SYRINGE | Ultimed, Inc., Disposable syringe - UltiCare® 1.5mL - Ultimed - safety
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K994230 | Class II | Active |
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Manufacturer
- Manufacturer
- Ultimed, Inc.
Sources (1)
- FDA 510(k) K994230 24 fields · synced Oct 1, 2026