# K012584: Modification to: BD Durasafe Plus Epidural Lock Cse Needle Set/Kit

- Pathway: 510(k) (Special)
- Applicant: Bd
- Decided: Sep 6, 2001 after 27 days
- Product code: CAZ (Anesthesia Conduction Kit)
- Device class: 2
- Regulation: 21 CFR 868.5140
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K945497 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945497: B-D Durasafe)TM) Variable Extension Combined Spinal Epidural *Cse) Needle Set/Kit, Bd Becton Dickinson Vacutainer Systems Preanalytic (1995) Summary page 1.

## Recalls of this device
- Sep 12, 2017 · Class II · Z-0725-2018: The tucking depth feature of this catheter introducer is marginally outside the upper specification.

## Indications for use
The BD Durasafe™ Plus! Epidural Lock CSE Needle Set/Kit is used to perform the combined spinal/epidural (CSE) anesthesia procedure.

Source page: https://510kreport.com/device/K012584
Methodology: https://510kreport.com/methodology