Cleared Traditional

K830294 - MEDICAL EXAM TABLE

K830294 is an FDA 510(k) clearance for MEDICAL EXAM TABLE, manufactured by Coe Laboratories, Inc.. The device is a Class 1 General Hospital device with product code LGX cleared through the Traditional 510(k) pathway after a 349-day FDA review.

K830294 · Coe Laboratories, Inc. · General Hospital
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Jan 1984
Decision
349d
Days
Class 1
Risk

K830294 is an FDA 510(k) clearance for the MEDICAL EXAM TABLE. Classified as Table, Examination, Medical, Powered (product code LGX), Class I - General Controls.

Submitted by Coe Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 11, 1984 after a review of 349 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Coe Laboratories, Inc. devices

FDA 510(k) Submission Details - K830294

510(k) Number K830294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1983
Decision Date January 11, 1984
Days to Decision 349 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
220d slower than avg
Panel avg: 129d · This submission: 349d
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 7
Devices cleared under the same product code (LGX) and FDA review panel - the closest regulatory comparables to K830294.
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
MULTIPLE, MODEL #17
K820823 · Midmark Corp. · Apr 1982
THREE MODELS OF TABLES, STOOLS, & LIGHTS
K811190 · Midmark Corp. · May 1981
CASTLE PROCEDURE AND RITTER EXAM. TABLES
K810900 · Sybron Corp. · Apr 1981