Cleared Traditional

HOLDSTER ARM RETENTION SYSTEM (K844157) - FDA 510(k) Clearance

K844157 · P.G.L. Medical · Physical Medicine device
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Jan 1985
Decision
91d
Days
-
Risk

K844157 is an FDA 510(k) clearance for the HOLDSTER ARM RETENTION SYSTEM.

Submitted by P.G.L. Medical (San Francisco, US). The FDA issued a Cleared decision on January 23, 1985 after a review of 91 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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.

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Submission Details

510(k) Number K844157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1984
Decision Date January 23, 1985
Days to Decision 91 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
24d faster than avg
Panel avg: 115d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -