Cleared Traditional

PORTABLE LIMB LOAD MONITOR (BMLLM-100) (K915326) - FDA 510(k) Clearance

Class I Physical Medicine device.

K915326 · Bar Med Pty , Ltd. · Physical Medicine device
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Oct 1992
Decision
333d
Days
Class 1
Risk

K915326 is an FDA 510(k) clearance for the PORTABLE LIMB LOAD MONITOR (BMLLM-100). Classified as Transducer, Miniature Pressure (product code IKE), Class I - General Controls.

Submitted by Bar Med Pty , Ltd. (Australia, AU). The FDA issued a Cleared decision on October 20, 1992 after a review of 333 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.1615 - the FDA physical medicine device framework. 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 Bar Med Pty , Ltd. devices

Submission Details

510(k) Number K915326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1991
Decision Date October 20, 1992
Days to Decision 333 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
218d slower than avg
Panel avg: 115d · This submission: 333d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IKE Transducer, Miniature Pressure
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.1615
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.