IRT Locking Syringe
by Interventional Research Technologies
510(k) K945410
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK945410 | Date19 Dec 1996 | 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- Withdrawn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 IRT Locking Syringe is a piston syringe designed for medical use, featuring a calibrated hollow barrel and a movable plunger. It incorporates a male connector (nozzle) at one end, intended to securely attach to the female connector (hub) of a hypodermic single-lumen needle. This locking mechanism enhances stability and prevents accidental dislodgement during use. The device falls under the classification of syringe, piston as defined by regulatory nomenclature.
This syringe is supplied as a single-use medical device and is regulated under FDA 510(k) clearance (K945410), classified under product code FMF and regulatory category 880.5860. It was determined Substantially Equivalent (SESE) to a predicate device by the FDA’s General Hospital Orthopaedic (HO) Advisory Committee in 1996. No additional sterility or MRI safety specifications are noted in the regulatory submission.
Questions
AI-generated answers, 1 Oct 2026
What is the IRT Locking Syringe designed for?
The IRT Locking Syringe is a piston-type syringe engineered to enhance stability during medical procedures. Its key feature is a male connector (nozzle) that securely locks onto the female connector (hub) of a single-lumen needle, preventing accidental dislodgement. This design is particularly useful in applications requiring precise fluid control, such as injections or infusions, where stability is critical.
How is the IRT Locking Syringe supplied, and is it reusable?
The IRT Locking Syringe is supplied as a single-use medical device. It is not intended for reuse, as single-use devices are designed for one-time clinical application to ensure sterility and patient safety. Reusing medical devices can introduce risks of contamination or mechanical failure, which is why regulatory standards like FDA 510(k) clearance emphasize single-use for syringes.
Does the IRT Locking Syringe have any special sterility or MRI safety requirements?
The regulatory submission for the IRT Locking Syringe does not specify additional sterility requirements beyond standard medical device practices for single-use items. There are also no noted MRI safety specifications, meaning it is not explicitly designed or tested for use in MRI environments. Always verify compatibility with facility protocols before use.
What regulatory pathway does the IRT Locking Syringe follow?
The IRT Locking Syringe follows the FDA’s 510(k) clearance pathway, specifically under clearance number K945410. It was classified under product code FMF and regulatory category 880.5860, with a decision of Substantially Equivalent (SESE) to a predicate device. This determination was made by the FDA’s General Hospital Orthopaedic (HO) Advisory Committee in 1996, ensuring it meets established safety and performance standards.
Are there different sizes or models available for the IRT Locking Syringe?
The provided regulatory data does not specify multiple sizes or models for the IRT Locking Syringe. However, the design emphasizes a locking mechanism for secure needle attachment, which may imply a standardized barrel and plunger configuration. For exact specifications, such as volume capacity or barrel length, refer to the manufacturer’s product documentation or contact Interventional Research Technologies directly.