Cleared Traditional

BURLINGTON STOCKINETTE (K822770) - FDA 510(k) Clearance

K822770 · Balfour, Inc. · Physical Medicine device
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Jul 1983
Decision
315d
Days
-
Risk

K822770 is an FDA 510(k) clearance for the BURLINGTON STOCKINETTE.

Submitted by Balfour, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 26, 1983 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Balfour, Inc. devices

Submission Details

510(k) Number K822770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1982
Decision Date July 26, 1983
Days to Decision 315 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
200d slower than avg
Panel avg: 115d · This submission: 315d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -