Cleared Traditional

DPM CALCULATOR (K810631) - FDA 510(k) Clearance

Class I Chemistry device.

K810631 · Iso-Data, Inc. · Chemistry device
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Mar 1981
Decision
17d
Days
Class 1
Risk

K810631 is an FDA 510(k) clearance for the DPM CALCULATOR. Classified as Calculator/data Processing Module, For Clinical Use (product code JQP), Class I - General Controls.

Submitted by Iso-Data, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 27, 1981 after a review of 17 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 Iso-Data, Inc. devices

Submission Details

510(k) Number K810631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1981
Decision Date March 27, 1981
Days to Decision 17 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 88d · This submission: 17d
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 K810631.
SYVA LAB PROCESSOR 6000
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BECKMAN DP-5500 DATA REDUCTION SYSTEM
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BIOSTATOR PRINTER/PLOTTER
K801210 · Miles Laboratories, Inc. · Jun 1980