Cleared Traditional

DP-5000 DATA REDUCTION SYSTEM (K770572) - FDA 510(k) Clearance

Class I Immunology device.

K770572 · Beckman Instruments, Inc. · Immunology device
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Apr 1977
Decision
21d
Days
Class 1
Risk

K770572 is an FDA 510(k) clearance for the DP-5000 DATA REDUCTION SYSTEM. Classified as Counter (beta, Gamma) For Clinical Use (product code JJJ), Class I - General Controls.

Submitted by Beckman Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 15, 1977 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.2320 - the FDA immunology 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 Beckman Instruments, Inc. devices

Submission Details

510(k) Number K770572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1977
Decision Date April 15, 1977
Days to Decision 21 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 104d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJJ Counter (beta, Gamma) For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2320
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 - JJJ Counter (beta, Gamma) For Clinical Use

All 12
Devices cleared under the same product code (JJJ) and FDA review panel - the closest regulatory comparables to K770572.
PRINTER
K772099 · Miles Laboratories, Inc. · Jan 1978
LIQ. SCINTILLATION SPECTROPHOTOMETEO
K771369 · Beckman Instruments, Inc. · Sep 1977
AUTO-LOGIC II SYSTEM
K771129 · Abbott Laboratories · Aug 1977
GAMMA 4000 SCINTILLATION COUNTER
K770088 · Beckman Instruments, Inc. · Feb 1977
WELL COUNTERS, LOGIC II (200 SERIES)
K761214 · Abbott Laboratories · Dec 1976
GAMMA SCINTILLATION COUNTER
K760900 · Beckman Instruments, Inc. · Nov 1976