Cleared Traditional

K823785 - API MDS*

K823785 is the FDA 510(k) clearance for API MDS* by Analytical Products, Inc.. It is a Class 1 Chemistry device (product code JQP) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K823785 · Analytical Products, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1983
Decision
24d
Days
Class 1
Risk

K823785 is an FDA 510(k) clearance for the API MDS*. Classified as Calculator/data Processing Module, For Clinical Use (product code JQP), Class I - General Controls.

Submitted by Analytical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 9, 1983 after a review of 24 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 Analytical Products, Inc. devices

Submission Details

510(k) Number K823785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1982
Decision Date January 09, 1983
Days to Decision 24 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 88d · This submission: 24d
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 K823785.
ACLAIM-QAP IBM PERSONAL COMPUTER EDT
K833353 · American Dade · Dec 1983
DUPONT LINEARIZATION MODULE
K832746 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1983
CORNING 102 PRINTER
K830296 · Corning Medical & Scientific · Mar 1983
QAP MICROCOMPUTER SYSTEM
K823110 · American Dade · Nov 1982
EMIT CLINICAL PROCESSOR #CP-5000
K822932 · Syva Co. · Nov 1982
RIA SSIST TI-59 MAGNETIC CARD PROGRAMS
K822860 · Ventrex Laboratories, Inc. · Oct 1982