Cleared Traditional

BIO-FEEDBACK LIMB MONITOR TYPE CODE BL-34-1 (K875103) - FDA 510(k) Clearance

Class I Physical Medicine device.

K875103 · Shield Computers , Ltd. · Physical Medicine device
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Jan 1988
Decision
41d
Days
Class 1
Risk

K875103 is an FDA 510(k) clearance for the BIO-FEEDBACK LIMB MONITOR TYPE CODE BL-34-1. Classified as Transducer, Miniature Pressure (product code IKE), Class I - General Controls.

Submitted by Shield Computers , Ltd. (Barnsley S70 1ll, GB). The FDA issued a Cleared decision on January 20, 1988 after a review of 41 days - a notably fast clearance cycle.

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: 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 Shield Computers , Ltd. devices

Submission Details

510(k) Number K875103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1987
Decision Date January 20, 1988
Days to Decision 41 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
74d faster than avg
Panel avg: 115d · This submission: 41d
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.