Cleared Traditional

K950560 - SALINE SOLUTINE, STERILE (FDA 510(k) Clearance)

Class I Pathology device.

K950560 · Busse Hospital Disposables, Inc. · Pathology device
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May 1995
Decision
111d
Days
Class 1
Risk

K950560 is an FDA 510(k) clearance for the SALINE SOLUTINE, STERILE. Classified as Solution, Formalin Ammonium Bromide (product code IGE), Class I - General Controls.

Submitted by Busse Hospital Disposables, Inc. (Hauppauge, US). The FDA issued a Cleared decision on May 30, 1995 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.4010 - the FDA pathology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Busse Hospital Disposables, Inc. devices

Submission Details

510(k) Number K950560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1995
Decision Date May 30, 1995
Days to Decision 111 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 77d · This submission: 111d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IGE Solution, Formalin Ammonium Bromide
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.4010
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.