# K964783: Epidural Mini Kit, Eldor Combined Spinal/Epidural Kit

- Pathway: 510(k) (Traditional)
- Applicant: Alexander Medical, Inc.
- Decided: Feb 12, 1997 after 77 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: 1 generation back to K894725 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932614: Regional Anaesthesia Tray, Mediziv Medical Products, Ltd. (1994) Summary page 1.
- K894725: Mediziv Epidural Systems, Mediziv Medical Devices, Ltd. (1989) Summary page 4.

## Cited in the summary but kept off the family tree
- K920076: Becton Dickinson Durasafe. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Indications for use
Delivery of Epidural anesthesia for the epidural kits and delivery of combined spinal/epidural anesthesia for the combined kits.

Source page: https://510kreport.com/device/K964783
Methodology: https://510kreport.com/methodology