# K970997: Neo-Care Lumber Puncture Kit

- Pathway: 510(k) (Traditional)
- Applicant: Klein-Baker Medical, Inc.
- Decided: May 22, 1997 after 64 days
- Product code: MIA (Needle, Spinal, Short Term)
- 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K052435: Pneumrx Family of Biopsy Needles and Kits (2005), 0 descendants of its own

## Indications for use
A single use, disposable. lumbar puncture kit for collection and sampling of spinal fluid from Neonatal patients.

Source page: https://510kreport.com/device/K970997
Methodology: https://510kreport.com/methodology