Epidural Kit: Contents Checklist and FDA Class II Status

General product information only, not medical advice. This page describes what an epidural kit is made of and how FDA classifies it. It does not describe how any device is used on a patient; that belongs to the manufacturer’s instructions for use (IFU) and the clinician’s training.

An epidural kit (also called an epidural tray or epidural anesthesia kit) is a pre-assembled set of single-use components for epidural catheter anesthesia. In the United States, FDA lists kits of this kind under the regulation for “anesthesia conduction kits”, 21 CFR 868.5140 (Class II), and files epidural and spinal kits under a catheter regulation, 21 CFR 868.5120. This page is for supply, central-processing and procurement staff who need a component checklist and a list of documents to ask a supplier for. For the wider question of how custom trays are regulated, see custom procedure trays: what FDA says and what to ask a supplier.

Purpose and setting

The kit exists so the components for one epidural catheter set arrive together, labeled and traceable to one lot. Where it is stocked (labor and delivery, operating rooms, pain clinics) is a facility decision; the pain-clinic side is covered in the pain management clinic supply checklist. Needle length and gauge are covered separately in how long are epidural needles.

What is in an epidural kit: component checklist

No FDA record or regulation lists the required contents of an epidural kit. Contents are set by each manufacturer, so the only reliable list is the one printed in the kit’s own IFU or contents sheet. The table below shows what one manufacturer, Vygon, publishes for its 4-item epidural mini-set (manufacturer product page, checked 2026-11-04). Other makers’ kits differ.

Item	What the Vygon 4-item mini-set lists	Why it is on the checklist
Epidural needle	Tuohy needle, 17 G, 90 mm	Gauge and length are the specification a buyer compares between kits
Epidural catheter	19 G, 90 cm long, 0.5 mm inside diameter, 1.0 mm outside diameter	Catheter dimensions are part of the specification a buyer compares between kits
Syringe	One 10 ml loss-of-resistance syringe	Syringe type and volume vary by kit
Filter	One filter (the product page does not state the pore size)	Ask the supplier for the filter specification in the IFU

The same page states the set is pyrogen-free, contains no latex and no animal-derived product, and is packed 20 per box. A mini-set is the smallest format; larger trays from other makers may add further components, so compare each kit against its own contents sheet rather than against this table.

Epidural tray vs spinal tray vs anesthesia kit

Epidural tray, epidural anesthesia kit

These are trade names for the same kind of product. FDA’s classification database has a product code named “Spinal Epidural Anesthesia Kit” (OFT) under 21 CFR 868.5120.

Spinal tray, spinal anesthesia kit

FDA has a separate product code, “Spinal Anesthesia Kit” (OFU), under the same regulation. A spinal tray is therefore a distinct listed kit type, not a synonym; its contents come from its own IFU. Spinal needles are classified separately, for example product code MIA, “Needle, Spinal, Short Term”, under 21 CFR 868.5150.

Anesthesia conduction kit

This is the broader regulatory name. 21 CFR 868.5140(a) defines it as “a device used to administer to a patient conduction, regional, or local anesthesia”, and paragraph (b) classifies it as Class II (performance standards). Product code CAZ, “Anesthesia Conduction Kit”, sits under it.

What varies between kits

• Component set: the number of items (the Vygon set has four) and which items are included.
• Needle and catheter dimensions: gauge, length and catheter inside and outside diameter, as in the table above.
• Connector type: ask the supplier which connector type the kit uses and where the IFU names it.
• Material statements: latex, animal-derived material and pyrogen statements are made per product by the manufacturer.
• Pack size: for example, 20 per box for the Vygon set.

What to verify before ordering

1. The IFU and a contents sheet for the exact catalogue number, since FDA records do not list contents.
2. Which FDA product code the manufacturer files the kit under (for example OFT, OFU or CAZ) and the regulation number.
3. The connector type named in the IFU.
4. The latex, pyrogen and animal-product statements for that catalogue number.
5. The lot number and expiry date printed on the label and the outer carton.

Storage, expiry and restocking

Storage conditions and shelf life are set by the manufacturer for each product and printed on the label and in the IFU. This page does not give generic storage temperatures or par levels, because no FDA record sets them for epidural kits.

Standards and rules that apply

• 21 CFR 868.5140, anesthesia conduction kit: definition and Class II classification (Cornell Legal Information Institute copy of the CFR, checked 2026-11-04; the official text is on eCFR).
• 21 CFR 868.5120, anesthesia conduction catheter: the regulation under which FDA’s database lists the spinal and epidural kit product codes OFT and OFU, both Class 2 (openFDA device classification database, checked 2026-11-04).
• FDA convenience kit guidance (20 May 1997): the product-code records for CAZ, OFT and OFU state that this type of convenience kit is under enforcement discretion and does not require a premarket notification (510(k)) if it meets all the criteria in that guidance. The criteria themselves are in the guidance, and compliance is the manufacturer’s responsibility.

FAQ

What is in an epidural kit?

It depends on the manufacturer. One published example, Vygon’s 4-item mini-set, contains an epidural needle, a catheter, a loss-of-resistance syringe and a filter. Always use the IFU for the exact catalogue number.

What is the difference between an epidural kit and a spinal kit?

FDA lists them as separate product types, OFT “Spinal Epidural Anesthesia Kit” and OFU “Spinal Anesthesia Kit”, both under 21 CFR 868.5120. Their contents are defined by each manufacturer.

Is an epidural kit a Class II device?

FDA classifies anesthesia conduction kits as Class II under 21 CFR 868.5140, and the OFT and OFU product codes are Class 2 under 21 CFR 868.5120. Many kits of this type are under enforcement discretion for 510(k) if they meet FDA’s convenience kit guidance.

What are epidural tray contents and spinal tray contents?

No regulation fixes them. Use the manufacturer’s contents sheet for each tray.

Sources

• 21 CFR 868.5140, Anesthesia conduction kit. https://www.law.cornell.edu/cfr/text/21/868.5140, checked 2026-11-04.
• 21 CFR 868.5120, Anesthesia conduction catheter. https://www.law.cornell.edu/cfr/text/21/868.5120, checked 2026-11-04.
• FDA device classification database via openFDA (https://api.fda.gov/device/classification.json?search=product_code:OFT), product codes CAZ, OFT, OFU, MIA; checked 2026-11-04.
• Vygon, epidural anaesthesia mini-sets, 4 items (Peristyl needle, catheter, syringe, filter), product page, https://www.vygon.com/en/products/nervous/standard-luer-range/epidural-anaesthesia-mini-sets/mini-sets-4-items-peristyl-needle-catheter-syringe-filter, checked 2026-11-04.
• Related CASRAI pages: lumbar drain kit contents checklist.