Cleared Traditional

BECKMAN DP-5500 DATA REDUCTION SYSTEM (K802594) - FDA 510(k) Clearance

Class I Chemistry device.

K802594 · Beckman Instruments, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1980
Decision
22d
Days
Class 1
Risk

K802594 is an FDA 510(k) clearance for the BECKMAN DP-5500 DATA REDUCTION SYSTEM. Classified as Calculator/data Processing Module, For Clinical Use (product code JQP), Class I - General Controls.

Submitted by Beckman Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 12, 1980 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2100 - 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 Beckman Instruments, Inc. devices

Submission Details

510(k) Number K802594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1980
Decision Date November 12, 1980
Days to Decision 22 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 88d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JQP Calculator/data Processing Module, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2100
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 - JQP Calculator/data Processing Module, For Clinical Use

All 29
Devices cleared under the same product code (JQP) and FDA review panel - the closest regulatory comparables to K802594.
SYVA LAB PROCESSOR 6000
K822381 · Syva Co. · Aug 1982
EMIT TIMER UNIT #100
K821531 · Syva Co. · Jun 1982
IL 8060 DATA MANAGEMENT SYSTEM
K820427 · Instrumentation Laboratory CO · Mar 1982
SERALYZER GLUCOSE TEST MODULE
K801664 · Miles Laboratories, Inc. · Aug 1980
BIOSTATOR PRINTER/PLOTTER
K801210 · Miles Laboratories, Inc. · Jun 1980
IL88640 & 88641 CASSETTE-TAPE PROGRAM
K801131 · Instrumentation Laboratory CO · May 1980