Cleared Traditional

BI-4520 DUAL IMPEDOMETER (K821723) - FDA 510(k) Clearance

K821723 · Farrall Instruments, Inc. · General & Plastic Surgery device
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Sep 1982
Decision
98d
Days
-
Risk

K821723 is an FDA 510(k) clearance for the BI-4520 DUAL IMPEDOMETER.

Submitted by Farrall Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 15, 1982 after a review of 98 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Farrall Instruments, Inc. devices

Submission Details

510(k) Number K821723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1982
Decision Date September 15, 1982
Days to Decision 98 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 115d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -