Cleared Traditional

K802251 - SP 120 SOPHISTICATE

K802251 is the FDA 510(k) clearance for SP 120 SOPHISTICATE by Vickers America Medical Corp.. It is a Class 1 Chemistry device (product code JQP) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K802251 · Vickers America Medical Corp. · Chemistry device
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Oct 1980
Decision
37d
Days
Class 1
Risk

K802251 is an FDA 510(k) clearance for the SP 120 SOPHISTICATE. Classified as Calculator/data Processing Module, For Clinical Use (product code JQP), Class I - General Controls.

Submitted by Vickers America Medical Corp. (Walker, US). The FDA issued a Cleared decision on October 23, 1980 after a review of 37 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 Vickers America Medical Corp. devices

Submission Details

510(k) Number K802251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1980
Decision Date October 23, 1980
Days to Decision 37 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 88d · This submission: 37d
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 42
Devices cleared under the same product code (JQP) and FDA review panel - the closest regulatory comparables to K802251.
715 DELTA TERMINAL
K821058 · Corning Medical & Scientific · May 1982
IL 8060 DATA MANAGEMENT SYSTEM
K820427 · Instrumentation Laboratory CO · Mar 1982
BECKMAN DP-5500 DATA REDUCTION SYSTEM
K802594 · Beckman Instruments, Inc. · Nov 1980
SERALYZER GLUCOSE TEST MODULE
K801664 · Miles Laboratories, Inc. · Aug 1980
CENTRIFICHEM SYSTEM MANAGER
K801438 · Union Carbide Corp. · Jul 1980
BIOSTATOR PRINTER/PLOTTER
K801210 · Miles Laboratories, Inc. · Jun 1980