Cleared Traditional

K902850 - ZEPPELIN INSTRUMENTS (FDA 510(k) Clearance)

Class I Neurology device.

K902850 · Ruggles Corp. · Neurology device
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Jul 1990
Decision
19d
Days
Class 1
Risk

K902850 is an FDA 510(k) clearance for the ZEPPELIN INSTRUMENTS. Classified as Instrument, Surgical, Non-powered (product code HAO), Class I - General Controls.

Submitted by Ruggles Corp. (No. Quincy, US). The FDA issued a Cleared decision on July 18, 1990 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4535 - 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 Ruggles Corp. devices

Submission Details

510(k) Number K902850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1990
Decision Date July 18, 1990
Days to Decision 19 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
129d faster than avg
Panel avg: 148d · This submission: 19d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HAO Instrument, Surgical, Non-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 882.4535
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.