# K041158: Atrion Epidural Anesthesia Kit with Atrion Needlevise Sharps Securing System

- Pathway: 510(k) (Traditional)
- Applicant: Atrion Medical Products, Inc.
- Decided: Jun 16, 2004 after 44 days
- Product code: CAZ (Anesthesia Conduction Kit)
- Device class: 2
- Regulation: 21 CFR 868.5140
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K801912 (1980). 6 ancestors in all.
No later device cites it as a predicate yet.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010038: Needle Barn Stick Stopper with Safety Cap, in Kit with Sterile Field Drape, Cambridge Marketing, Inc. (2001) Summary page 1.
- K946289: Devons Point Lok Needle Protection Device, Devon Industries, Inc. (1995) Summary page 1.
- K971233: Soft Tip Epidural Catheter Kit, B.Braun Medical, Inc. (1997) Summary page 1.
- K802065: Continuous Epidural Anesthesia Tray/Drug, Portex, Inc. (1980) Summary page 1.

## Indications for use
The Atrion Epidural Anesthesia Kit is intended for use in the administration of anesthetic agents into the epidural space. It is recommended that the epidural catheter be removed or replace every 72 hours. The NeedleVISETM sharps securing system is intended for use in sterile anesthesiology procedure trays within the sterile field as a sharps securing device for the contaminated specialized needles that do not have integral engineered sharps safety devices.

Source page: https://510kreport.com/device/K041158
Methodology: https://510kreport.com/methodology