Cleared Traditional

K833113 - REPORTING INTEGRATOR 3392A

K833113 is the FDA 510(k) clearance for REPORTING INTEGRATOR 3392A by Hewlett-Packard Co.. It is a Class 1 Toxicology device (product code LDM) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K833113 · Hewlett-Packard Co. · Toxicology device
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Nov 1983
Decision
69d
Days
Class 1
Risk

K833113 is an FDA 510(k) clearance for the REPORTING INTEGRATOR 3392A. Classified as Instrumentation, High Pressure Liquid Chromatography (product code LDM), Class I - General Controls.

Submitted by Hewlett-Packard Co. (Walker, US). The FDA issued a Cleared decision on November 21, 1983 after a review of 69 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 K833113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1983
Decision Date November 21, 1983
Days to Decision 69 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
18d faster than avg
Panel avg: 87d · This submission: 69d
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

All 17
Devices cleared under the same product code (LDM) and FDA review panel - the closest regulatory comparables to K833113.
ISOPURE LC SYSTEM
K862178 · The Perkin-Elmer Corp. · Jul 1986
WATERS 740 DATA MODULE-PLOTTER INTEGRATOR
K850272 · Millipore Corp. · Mar 1985
WATERS 460 LIQUID CHROMATOGRAPHY ELECTROCHEMICAL D
K850359 · Millipore Corp. · Mar 1985
LIQUID CHROMATOGRAPH 1090 SERIES
K832375 · Hewlett-Packard Co. · Oct 1983
SERIES 10 LIQUID CHROMOTOGRAPH
K821727 · The Perkin-Elmer Corp. · Jun 1982
SERIES 4 LIQUID CHROMATOGRAPH
K821219 · The Perkin-Elmer Corp. · May 1982