Cleared Traditional

QUANTROLS IM (K771941) - FDA 510(k) Clearance

K771941 · Organon, Inc. · Immunology device
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Nov 1977
Decision
16d
Days
-
Risk

K771941 is an FDA 510(k) clearance for the QUANTROLS IM.

Submitted by Organon, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 2, 1977 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel. 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 Organon, Inc. devices

Submission Details

510(k) Number K771941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1977
Decision Date November 02, 1977
Days to Decision 16 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 104d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -