Cleared Traditional

K792129 - EMIT CLINICAL PROCESSOR-CP 5000

K792129 is the FDA 510(k) clearance for EMIT CLINICAL PROCESSOR-CP 5000 by Syva Co.. It is a Class 1 Toxicology device (product code JQP) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K792129 · Syva Co. · Toxicology device
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Nov 1979
Decision
20d
Days
Class 1
Risk

K792129 is an FDA 510(k) clearance for the EMIT CLINICAL PROCESSOR-CP 5000. Classified as Calculator/data Processing Module, For Clinical Use (product code JQP), Class I - General Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on November 13, 1979 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2100 - 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 Syva Co. devices

Submission Details

510(k) Number K792129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1979
Decision Date November 13, 1979
Days to Decision 20 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
67d faster than avg
Panel avg: 87d · This submission: 20d
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 48
Devices cleared under the same product code (JQP) and FDA review panel - the closest regulatory comparables to K792129.
AMES LAB MANAGEMENT SYSTEM
K800724 · Miles Laboratories, Inc. · Apr 1980
DATA MANAGEMENT SYSTEM IL MODEL 775
K800282 · Instrumentation Laboratory CO · Mar 1980
3388 REPORTING INTEGRATOR
K792158 · Hewlett-Packard Co. · Nov 1979
THE ABBOTT EXECUTIVE
K790543 · Abbott Laboratories · May 1979
UNION CARBIDE CORP. COMPUTER INTERFACE
K790336 · Union Carbide Corp. · Apr 1979
PROCESSOR, K750 COMPUTER/DATA
K782052 · Kallestad Laboratories, Inc. · Jan 1979