Cleared Traditional

K902549 - TITAN GLADIATOR ADJUSTING TABLE

K902549 is an FDA 510(k) clearance for TITAN GLADIATOR ADJUSTING TABLE, manufactured by Titan Tables. The device is a Class 1 Physical Medicine device with product code INQ cleared through the Traditional 510(k) pathway after a 5-day FDA review.

K902549 · Titan Tables · Physical Medicine device
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Jun 1990
Decision
5d
Days
Class 1
Risk

K902549 is an FDA 510(k) clearance for the TITAN GLADIATOR ADJUSTING TABLE. Classified as Table, Powered (product code INQ), Class I - General Controls.

Submitted by Titan Tables (Camdenton, US). The FDA issued a Cleared decision on June 13, 1990 after a review of 5 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3760 - the FDA physical medicine 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 Titan Tables devices

FDA 510(k) Submission Details - K902549

510(k) Number K902549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1990
Decision Date June 13, 1990
Days to Decision 5 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 115d · This submission: 5d
Pathway characteristics
Predicate-based equivalence.

INQ Device Classification - Class 1, General Controls

Product Code INQ Table, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3760
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 - INQ Table, Powered

All 49
Devices cleared under the same product code (INQ) and FDA review panel - the closest regulatory comparables to K902549.
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POWER PODIATRY CHAIR/TABLE #414, #416 & #417
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R1698,R1701,R1215,R1700 & R860 POWERED TABLES
K861352 · Tri W-G, Inc. · May 1986