Cleared Traditional

K810968 - BCD-HPP41C INTERFACE

K810968 is the FDA 510(k) clearance for BCD-HPP41C INTERFACE by Dynatech Corp.. It is a Class 1 Immunology device (product code JQP) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K810968 · Dynatech Corp. · Immunology device
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Apr 1981
Decision
14d
Days
Class 1
Risk

K810968 is an FDA 510(k) clearance for the BCD-HPP41C INTERFACE. Classified as Calculator/data Processing Module, For Clinical Use (product code JQP), Class I - General Controls.

Submitted by Dynatech Corp. (Mchenry, US). The FDA issued a Cleared decision on April 23, 1981 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.2100 - the FDA immunology 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 Dynatech Corp. devices

Submission Details

510(k) Number K810968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1981
Decision Date April 23, 1981
Days to Decision 14 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 104d · This submission: 14d
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 49
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