Cleared Traditional

HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103 (K021622) - FDA 510(k) Clearance

Class I Chemistry device.

K021622 · Hill-Rom Air-Shields · Chemistry device
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Apr 2003
Decision
320d
Days
Class 1
Risk

K021622 is an FDA 510(k) clearance for the HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103. Classified as Bilirubin (total And Unbound) In The Neonate Test System (product code MQM), Class I - General Controls.

Submitted by Hill-Rom Air-Shields (Hatboro, US). The FDA issued a Cleared decision on April 1, 2003 after a review of 320 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1113 - 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. Elevated predicate reliance profile. 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 Hill-Rom Air-Shields devices

Submission Details

510(k) Number K021622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2002
Decision Date April 01, 2003
Days to Decision 320 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
232d slower than avg
Panel avg: 88d · This submission: 320d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MQM Bilirubin (total And Unbound) In The Neonate Test System
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1113
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.