Cleared Traditional

GONIOMETER AND BIOMEDICAL RECORDER SYSTEM (K884003) - FDA 510(k) Clearance

Class I Neurology device.

K884003 · Penny & Giles Blackwood , Ltd. · Neurology device
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Dec 1988
Decision
89d
Days
Class 1
Risk

K884003 is an FDA 510(k) clearance for the GONIOMETER AND BIOMEDICAL RECORDER SYSTEM. Classified as Goniometer, Ac-powered (product code KQX), Class I - General Controls.

Submitted by Penny & Giles Blackwood , Ltd. (England, GB). The FDA issued a Cleared decision on December 19, 1988 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 888.1500 - the FDA neurology 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 Penny & Giles Blackwood , Ltd. devices

Submission Details

510(k) Number K884003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1988
Decision Date December 19, 1988
Days to Decision 89 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 148d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KQX Goniometer, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.1500
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.