Cleared Traditional

K950415 - FLUOROSCAN NEONATAL

K950415 is an FDA 510(k) clearance for FLUOROSCAN NEONATAL, manufactured by Isolab, Inc.. The device is a Class 1 Chemistry device with product code KHO cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K950415 · Isolab, Inc. · Chemistry device
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Sep 1995
Decision
217d
Days
Class 1
Risk

K950415 is an FDA 510(k) clearance for the FLUOROSCAN NEONATAL. Classified as Fluorometer, For Clinical Use (product code KHO), Class I - General Controls.

Submitted by Isolab, Inc. (Akron, US). The FDA issued a Cleared decision on September 5, 1995 after a review of 217 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2560 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Isolab, Inc. devices

FDA 510(k) Submission Details - K950415

510(k) Number K950415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1995
Decision Date September 05, 1995
Days to Decision 217 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
129d slower than avg
Panel avg: 88d · This submission: 217d
Pathway characteristics
Predicate-based equivalence.

KHO Device Classification - Class 1, General Controls

Product Code KHO Fluorometer, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2560
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.

Regulatory Peers - KHO Fluorometer, For Clinical Use

All 31
Devices cleared under the same product code (KHO) and FDA review panel - the closest regulatory comparables to K950415.
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