510(k) Report

510(k) · Cleared

Recalled · Class II · 2017

Busse Hospital Disposables Spinal Manometer

K032432510(k) TraditionalCleared Aug 28, 200322-day reviewClass II21 CFR 880.2500Recalls 7

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Busse Hospital Disposables, Inc. · FMJ Manometer, Spinal-Fluid

Cleared on Aug 28, 2003 after a 22-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled 7 times.

Decided
Aug 28, 2003
Review
22 days
Class
Class II
Product code
FMJ
Recalls
7
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2017: 1 descendant cleared200020052010201520202025
  1. This deviceK032432 Busse Hospital Disposables Spinal ManometerBusse Hospital Disposables, Inc. · 2003
  2. Descendant · cites it directly · 0 of its ownK170305 Spinal Manometer NRFit; Spinal Manometer LUERPAJUNK GmbH Medizintechnologie · 2017

Most influential descendants

Showing 1 of 1 · See all
  • K170305Spinal Manometer NRFit; Spinal Manometer LUERPAJUNK GmbH Medizintechnologie · 2017 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K032432Busse Hospital Disposables Spinal ManometerBusse Hospital Disposables, Inc.2003—
+1K170305Spinal Manometer NRFit; Spinal Manometer LUERPAJUNK GmbH Medizintechnologie2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
FIG. 1 — Lineage of K032432, 2003–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FMJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*—Alleghence Spinal Manometer
Named without a submission number
—
*—B. Braun Spinal Manometer
Named without a submission number
—
*—SIMS Spinal Manometer
Named without a submission number
—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K170305Spinal Manometer NRFit; Spinal Manometer LUERPAJUNK GmbH Medizintechnologie20170

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jun 27, 2017Class IIZ-0540-2018Nonconforming Material/ComponentBD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.
Jun 27, 2017Class IIZ-0543-2018Nonconforming Material/ComponentBD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.
Jun 27, 2017Class IIZ-0545-2018Nonconforming Material/ComponentBD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.
Jun 27, 2017Class IIZ-0541-2018Nonconforming Material/ComponentBD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.
Jun 27, 2017Class IIZ-0542-2018Nonconforming Material/ComponentBD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.
Jun 27, 2017Class IIZ-0544-2018Nonconforming Material/ComponentBD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.
Jun 27, 2017Class IIZ-0546-2018Nonconforming Material/ComponentBD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.

The 5 latest of 7 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K170305 (PAJUNK GmbH Medizintechnologie, 2017) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FMJ devices

FMJ Manometer, Spinal-Fluid: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FMJ

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMJ

Too few FMJ 510(k)s in any year since 2007 to give a median.

Recalls per year · FMJ

No recall names FMJ since 2007.

Adverse event reports per year · FMJ

1in 2025

2007: 12009: 12010: 72011: 12012: 282013: 1012014: 1762015: 842019: 12023: 12025: 1
2007high 176 (2014) · low 0 (2008)2025

MAUDE reports naming product code FMJ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—01
20080—00
20090—01
20100—07
20110—01
20120—028
20130—0101
20140—0176
20150—084
20160—00
20171—00
20180—00
20190—01
20200—00
20210—00
20220—00
20230—01
20240—00
20250—01
20260—0—

What is it indicated for?

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

Indications for use as stated in the FDA summary.

More from Busse Hospital Disposables, Inc.

31 FDA decisions under this applicant name. See the company

  • K120002I-Style Bone Marrow Aspiration Needle with T-HandleBusse Hospital Disposables, Inc. · 2012
  • K093909Busse Surgical Drapes IVBusse Hospital Disposables, Inc. · 2010
  • K092212Busse Surgical Drapes IiiBusse Hospital Disposables, Inc. · 2009
  • K082297Busse Surgical DrapeBusse Hospital Disposables, Inc. · 2008
  • K073222Modification to:Specialty NeedlesBusse Hospital Disposables, Inc. · 2008

Recent decisions in FMJ

The FMJ category page

  • K170305Spinal Manometer NRFit; Spinal Manometer LUERPAJUNK GmbH Medizintechnologie · 2017
  • K970287Lumbar Puncture KitB.Braun Medical, Inc. · 1997
  • K963570Sims Adult Lumbar Puncture Kit (4800-20,4801-20,4806-22,4807-22)Smiths Industries Medical Systems, Inc. · 1996
  • K910089Mega Lumbar Puncture KitMegadyne Medical Products, Inc. · 1991
  • K882405Hypodermic Needle Sheath HolderAnsr Ent., Inc. · 1988

https://510kreport.com/device/K032432 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032432: Busse Hospital Disposables Spinal Manometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032432

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026