Cleared Traditional

K882010 - POWER EXAMINATION TABLE

K882010 is an FDA 510(k) clearance for POWER EXAMINATION TABLE, manufactured by Enochs Mfg., Inc.. The device is a Class 1 General Hospital device with product code LGX cleared through the Traditional 510(k) pathway after a 61-day FDA review.

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

FDA 510(k) Submission Details - K882010

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.

LGX Device Classification - Class 1, General Controls

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.

Regulatory Peers - LGX Table, Examination, Medical, Powered

All 8
Devices cleared under the same product code (LGX) and FDA review panel - the closest regulatory comparables to K882010.
ECHOCARDIOGRAPHY
K945163 · Tri W-G, Inc. · Feb 1995
POWER EXAMINATION TABLE MODEL # 411
K894134 · Midmark Corp. · Aug 1989
POWER EXAMINATION TABLE MODEL # 405
K894144 · Midmark Corp. · Aug 1989
STORZ PLASTIC SURGERY & EXAMINATION LOUNGE 7000
K845023 · Storz Instrument Co. · Jan 1985
MEDICAL EXAM TABLE
K830294 · Coe Laboratories, Inc. · Jan 1984
MULTIPLE, MODEL #17
K820823 · Midmark Corp. · Apr 1982