Cleared Traditional

K051261 - DYNATRON X3

K051261 is the FDA 510(k) clearance for DYNATRON X3 by Dynatronics Corp.. It is a Class 2 Physical Medicine device (product code ILY) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K051261 · Dynatronics Corp. · Physical Medicine device
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Jul 2005
Decision
70d
Days
Class 2
Risk

K051261 is an FDA 510(k) clearance for the DYNATRON X3 , DYNATRON XP IR LIGHT PAD, D405 IR LIGHT PROBE. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Dynatronics Corp. (Salt Lake City, US). The FDA issued a Cleared decision on July 25, 2005 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5500 - 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 Dynatronics Corp. devices

Submission Details

510(k) Number K051261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2005
Decision Date July 25, 2005
Days to Decision 70 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 115d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ILY Lamp, Infrared, Therapeutic Heating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5500
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - ILY Lamp, Infrared, Therapeutic Heating

All 13
Devices cleared under the same product code (ILY) and FDA review panel - the closest regulatory comparables to K051261.
ASA 'MPHI FAMILY DIODE LASER
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HILT FAMILY LASER: HILT I, HILT II, HILT III
K051537 · Cynosure, Inc. · Sep 2005
ASA 'M FAMILY' DIODE LASER, MODEL MI, MIX5, M6
K051922 · Cynosure, Inc. · Sep 2005
SURGICAL PATIENT WARMER, MODEL PW820 JHU
K022609 · Fisher &Paykel Healthcare , Ltd. · Mar 2003
PATIENT WARMER- MODEL PW810
K982636 · Fisher &Paykel Healthcare , Ltd. · Oct 1998