Cleared Traditional

POWER EXAMINATION TABLE (K882010) - FDA 510(k) Clearance

Class I General Hospital device.

K882010 · Enochs Mfg., Inc. · General Hospital
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Jul 1988
Decision
61d
Days
Class 1
Risk

K882010 is an FDA 510(k) clearance for the POWER EXAMINATION TABLE. Classified as Table, Examination, Medical, Powered (product code LGX), Class I - General Controls.

Submitted by Enochs Mfg., Inc. (Indianapolis, US). The FDA issued a Cleared decision on July 13, 1988 after a review of 61 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4960 - the FDA general hospital 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 Enochs Mfg., Inc. devices

Submission Details

510(k) Number K882010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1988
Decision Date July 13, 1988
Days to Decision 61 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 129d · This submission: 61d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LGX Table, Examination, Medical, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4960
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.