Cleared Traditional

JAYCO HYDROGEN MONITOR (K882499) - FDA 510(k) Clearance

Class I Chemistry device.

K882499 · Enteron, Inc. · Chemistry device
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Jun 1988
Decision
11d
Days
Class 1
Risk

K882499 is an FDA 510(k) clearance for the JAYCO HYDROGEN MONITOR. Classified as System, Breath Measurement (product code NRH), Class I - General Controls.

Submitted by Enteron, Inc. (Camp Hill, US). The FDA issued a Cleared decision on June 28, 1988 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1820 - 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: 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 Enteron, Inc. devices

Submission Details

510(k) Number K882499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1988
Decision Date June 28, 1988
Days to Decision 11 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 88d · This submission: 11d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NRH System, Breath Measurement
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1820
Definition Breath Measurement Systems Are Used To Measure Constituents Of Exhaled Breath As An Aid In The Diagnosis Of Sugar/nutrient Malabsorbtion And Other Conditions.
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.