Disposable Syringe
510(k) K882335
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK882335 | Date16 Jun 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- Withdrawn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
- FMF
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5860
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Disposable Syringe is a single-use medical device classified as a Syringe, Piston (product code FMF). It is designed for the accurate administration, aspiration, or transfer of liquids in clinical settings, ensuring sterile and precise dosing without risk of cross-contamination between patients. Constructed for one-time use, it eliminates the need for cleaning or reprocessing, reducing infection risks. These syringes are commonly used in general hospital procedures, including intravenous preparations, medication administration, and enteral feeding.
Disposable Syringes are supplied in sterile packaging and intended for single-use only to maintain hygiene and safety standards. They are available in various sizes, including 0.5 mL, 1 mL, 3 mL, 12 mL, and 20 mL, with some models featuring connectors like the ENFit system for compatibility with feeding tubes or IV lines. Storage should follow manufacturer guidelines to preserve sterility, typically in a clean, dry environment away from direct sunlight. The device holds an FDA 510(k) clearance (K882335) under the General Hospital advisory committee classification, ensuring compliance with regulatory requirements for Class II medical devices.
Other devices from Baxter Healthcare Corp
Questions
AI-generated answers, 1 Oct 2026
What is the Baxter Disposable Syringe designed for?
The Baxter Disposable Syringe is engineered for accurate administration, aspiration, or transfer of liquids in clinical environments. Its primary uses include intravenous medication preparation, medication dosing, and enteral feeding. The design ensures sterile and precise delivery while eliminating cross-contamination risks, making it ideal for general hospital procedures.
How are these syringes supplied and what does that mean for sterility?
The syringes are supplied in sterile packaging, which means they are pre-sterilized to prevent contamination before use. This packaging ensures the device remains sterile until opened, reducing infection risks during clinical procedures. The single-use nature further guarantees sterility, as reuse is not intended or safe.
Are these syringes reusable or single-use, and why?
These syringes are explicitly designed for single-use only. Baxter’s classification as a disposable device under FDA 510(k) clearance (K882335) reinforces this restriction. Reuse could compromise sterility, introduce contamination, and violate regulatory compliance, posing risks to patient safety and procedural integrity.
What sizes and connector options are available for the Baxter Disposable Syringe?
The Baxter Disposable Syringe comes in multiple sizes: 0.5 mL, 1 mL, 3 mL, 12 mL, and 20 mL. Some models feature ENFit connectors, which enhance compatibility with feeding tubes or IV lines, ensuring secure and leak-proof connections during clinical procedures.
How should these syringes be stored to maintain sterility?
Storage should follow Baxter’s guidelines to preserve sterility: keep syringes in a clean, dry environment away from direct sunlight. Unopened, sterile packaging should remain intact until use. Proper storage prevents moisture absorption, dust contamination, or degradation of the syringe’s integrity, ensuring reliability when needed.