# K970287: Lumbar Puncture Kit

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Apr 7, 1997 after 73 days
- Product code: FMJ (Manometer, Spinal-Fluid)
- Device class: 2
- Regulation: 21 CFR 880.2500
- 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 K920305 (1993). 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)
- K932569: Pencil Point Spinal Needle and Tray, B. Braun of America, Inc. (1994) Summary page 1.
- K920305: Pharmaseal Clear Hub Spinal Needle, Baxter Healthcare Corp (1993) Summary page 1.

## Indications for use
The Lumbar Puncture Kit is designed to collect samples of cerebralspinal fluid (CSF) from a patient while undergoing a lumbar puncture procedure. This device is also designed to attach a manometer to measure intracranial pressure (ICP), detect blood in CSF, inject dyes and gasses into the spine for radiologic studies, and to administer drugs or anesthesia between the third and fourth lumbar vertebrae in adult or pediatric patients.

Source page: https://510kreport.com/device/K970287
Methodology: https://510kreport.com/methodology