# K032432: Busse Hospital Disposables Spinal Manometer

- Pathway: 510(k) (Traditional)
- Applicant: Busse Hospital Disposables, Inc.
- Decided: Aug 28, 2003 after 22 days
- Product code: FMJ (Manometer, Spinal-Fluid)
- Device class: 2
- Regulation: 21 CFR 880.2500
- Recalls of this device: 7 (0 Class I)
- 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. The FDA summary names its predicate without a number.
- (no number) Alleghence Spinal Manometer: named in the summary without a submission number
- (no number) B. Braun Spinal Manometer: named in the summary without a submission number
- (no number) SIMS Spinal Manometer: named in the summary without a submission number

## Most influential descendants
- K170305: Spinal Manometer NRFit; Spinal Manometer LUER (2017), 0 descendants of its own

## Recalls of this device
- Jun 27, 2017 · Class II · Z-0540-2018: BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.
- Jun 27, 2017 · Class II · Z-0543-2018: BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.
- Jun 27, 2017 · Class II · Z-0545-2018: BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.
- Jun 27, 2017 · Class II · Z-0541-2018: BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.
- Jun 27, 2017 · Class II · Z-0542-2018: BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.
- Jun 27, 2017 · Class II · Z-0544-2018: BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.
- Jun 27, 2017 · Class II · Z-0546-2018: BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.

## Indications for use
The device is intended to measure the pressure of the Cerebrospinal Fluid (CSF) during a lumbar puncture procedure.

Source page: https://510kreport.com/device/K032432
Methodology: https://510kreport.com/methodology