Identifiers
- 510(k) Number
- K210983 FDA 510(k)
- FDA Product Code
- CAZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5140 FDA 510(k)
- Regulation Number
- 868.5140 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BD Epilor Loss-of-Resistance Syringe is a Plastic Syringe designed for loss-of-resistance (LOR) testing in epidural anesthesia procedures. It features a plunger rod with a double-ribbed stopper to facilitate smooth movement and prevent leakage during aspiration, aiding in the precise identification of the epidural space prior to anesthesia administration.
This device is supplied as a sterile, single-use syringe in 7 mL capacity, available with either Luer-Lok or slip-tip connectors. It is classified as a Class II medical device under FDA regulation 21 CFR 868.5140, with FDA 510(k) clearance (K210983). The syringe is intended for use in anesthesiology settings and must be handled in accordance with standard sterile technique.
Frequently asked questions
What is the primary purpose of the BD Epilor Syringe in clinical practice?
The BD Epilor Syringe is specifically designed for loss-of-resistance (LOR) testing during epidural anesthesia procedures. It helps anesthesiologists identify the epidural space by allowing precise aspiration and resistance assessment before administering anesthesia, ensuring accurate needle placement.
Is the BD Epilor Syringe reusable, or is it intended for single-use only?
The BD Epilor Syringe is sterile and intended for single-use only. Like all sterile medical devices, it must be discarded after one procedure to maintain infection control and regulatory compliance.
What connector types are available for the BD Epilor Syringe, and how does this affect compatibility?
The BD Epilor Syringe is available with two connector types: Luer-Lok and slip-tip. The Luer-Lok design provides a secure, screw-type connection for reliable attachment to needles or catheters, while the slip-tip offers a simpler, friction-fit alternative. This dual option ensures compatibility with various epidural anesthesia setups.
How should the BD Epilor Syringe be stored to preserve its sterility and functionality?
The BD Epilor Syringe must be stored in its original, unopened packaging to maintain sterility. It should be kept in a clean, dry environment away from direct sunlight or extreme temperatures, as recommended for all sterile medical devices. Avoid exposure to moisture or contamination.
What capacity does the BD Epilor Syringe have, and why is this size appropriate for LOR testing?
The BD Epilor Syringe has a 7 mL capacity, which is ideal for LOR testing because it provides enough volume to detect resistance changes during aspiration while remaining compact enough for precise handling in epidural procedures. The size balances functionality with ease of use.
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: BD Epilor™ Plastic LOR 7 mL with BD Luer-Lok™ Syringe, BD Epilor Plastic LOR 7 mL Syringes - Vitality Medical, BD (company) - Wikipedia, BD Epilor Syringe (K210983) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K210983 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K210983 24 fields · synced Sep 18, 2026