Cleared Traditional

K834168 - FIBRINOGEN UPTAKE SYS -VARIOUS MODELS (FDA 510(k) Clearance)

Class I Radiology device.

K834168 · Canberra Industries, Inc. · Radiology device
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Dec 1983
Decision
55d
Days
Class 1
Risk

K834168 is an FDA 510(k) clearance for the FIBRINOGEN UPTAKE SYS -VARIOUS MODELS. Classified as Snare, Ear (product code JZD), Class I - General Controls.

Submitted by Canberra Industries, Inc. (Meriden, US). The FDA issued a Cleared decision on December 29, 1983 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 874.4420 - the FDA radiology and imaging software oversight 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 Canberra Industries, Inc. devices

Submission Details

510(k) Number K834168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1983
Decision Date December 29, 1983
Days to Decision 55 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 107d · This submission: 55d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JZD Snare, Ear
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4420
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.