Cleared Traditional

3390A REPORTING INTEGRATOR (K802031) - FDA 510(k) Clearance

Class I Toxicology device.

K802031 · Hewlett-Packard Co. · Toxicology device
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Sep 1980
Decision
26d
Days
Class 1
Risk

K802031 is an FDA 510(k) clearance for the 3390A REPORTING INTEGRATOR. Classified as Instrumentation, High Pressure Liquid Chromatography (product code LDM), Class I - General Controls.

Submitted by Hewlett-Packard Co. (Mchenry, US). The FDA issued a Cleared decision on September 16, 1980 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2260 - the FDA toxicology 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 Hewlett-Packard Co. devices

Submission Details

510(k) Number K802031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1980
Decision Date September 16, 1980
Days to Decision 26 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 87d · This submission: 26d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LDM Instrumentation, High Pressure Liquid Chromatography
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2260
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 - LDM Instrumentation, High Pressure Liquid Chromatography

Devices cleared under the same product code (LDM) and FDA review panel - the closest regulatory comparables to K802031.
BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM
K942451 · Bio-Rad · Nov 1994
REPORTING INTEGRATOR 3392A
K833113 · Hewlett-Packard Co. · Nov 1983
LIQUID CHROMATOGRAPH 1090 SERIES
K832375 · Hewlett-Packard Co. · Oct 1983
PREP I AUTOMATED SAMPLE PROCESSOR
K780933 · E.I. Dupont DE Nemours & Co., Inc. · Jul 1978