Cleared Traditional

K032432 - BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER

K032432 is an FDA 510(k) clearance for BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER, manufactured by Busse Hospital Disposables, Inc.. The device is a Class 2 General Hospital device with product code FMJ cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K032432 · Busse Hospital Disposables, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
22d
Days
Class 2
Risk

K032432 is an FDA 510(k) clearance for the BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER. Classified as Manometer, Spinal-fluid (product code FMJ), Class II - Special Controls.

Submitted by Busse Hospital Disposables, Inc. (Huntington, US). The FDA issued a Cleared decision on August 28, 2003 after a review of 22 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2500 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Busse Hospital Disposables, Inc. devices

FDA 510(k) Submission Details - K032432

510(k) Number K032432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2003
Decision Date August 28, 2003
Days to Decision 22 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 129d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMJ Device Classification - Class 2, Special Controls

Product Code FMJ Manometer, Spinal-fluid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2500
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FMJ Manometer, Spinal-fluid

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