# K013892: Lutz Needle

- Pathway: 510(k) (Traditional)
- Applicant: Ballard Medical Products
- Decided: Jul 11, 2002 after 230 days
- Product code: BSP (Needle, Conduction, Anesthetic (W/Wo Introducer))
- Device class: 2
- Regulation: 21 CFR 868.5150
- 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 K000495 (2000). 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)
- K000495: Ballard Medical Products Epidural and Spinal Needles, Ballard Medical Products (2000) Summary page 1.

## Cited in the summary but kept off the family tree
- K923400: Dermco a-I, Dermaco, Inc. (1992). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
To introduce single-shot anesthetic agents into the epidural space.

Source page: https://510kreport.com/device/K013892
Methodology: https://510kreport.com/methodology