Cleared Traditional

MICRO MEDICAL DATA SYSTEM (K800241) - FDA 510(k) Clearance

Class I Chemistry device.

K800241 · Micro/Tel., Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1980
Decision
21d
Days
Class 1
Risk

K800241 is an FDA 510(k) clearance for the MICRO MEDICAL DATA SYSTEM. Classified as Calculator/data Processing Module, For Clinical Use (product code JQP), Class I - General Controls.

Submitted by Micro/Tel., Inc. (Mchenry, US). The FDA issued a Cleared decision on February 26, 1980 after a review of 21 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 Micro/Tel., Inc. devices

Submission Details

510(k) Number K800241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1980
Decision Date February 26, 1980
Days to Decision 21 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 88d · This submission: 21d
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 30
Devices cleared under the same product code (JQP) and FDA review panel - the closest regulatory comparables to K800241.
IL88640 & 88641 CASSETTE-TAPE PROGRAM
K801131 · Instrumentation Laboratory CO · May 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
EMIT CLINICAL PROCESSOR-CP 5000
K792129 · Syva Co. · Nov 1979
THE ABBOTT EXECUTIVE
K790543 · Abbott Laboratories · May 1979