Cleared Traditional

K801131 - IL88640 & 88641 CASSETTE-TAPE PROGRAM

K801131 is the FDA 510(k) clearance for IL88640 & 88641 CASSETTE-TAPE PROGRAM by Instrumentation Laboratory CO. It is a Class 1 Toxicology device (product code JQP) cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K801131 · Instrumentation Laboratory CO · Toxicology device
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May 1980
Decision
11d
Days
Class 1
Risk

K801131 is an FDA 510(k) clearance for the IL88640 & 88641 CASSETTE-TAPE PROGRAM. Classified as Calculator/data Processing Module, For Clinical Use (product code JQP), Class I - General Controls.

Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on May 23, 1980 after a review of 11 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 Instrumentation Laboratory CO devices

Submission Details

510(k) Number K801131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1980
Decision Date May 23, 1980
Days to Decision 11 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
76d faster than avg
Panel avg: 87d · This submission: 11d
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 46
Devices cleared under the same product code (JQP) and FDA review panel - the closest regulatory comparables to K801131.
BIOSTATOR PRINTER/PLOTTER
K801210 · Miles Laboratories, Inc. · Jun 1980
K 750 COMPUTER/DATA PROCESSOR
K801091 · J.T. Baker Chemical Co. · Jun 1980
CENTRIFICHEM SYSTEM 400
K801167 · Union Carbide Corp. · Jun 1980
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