Cleared Traditional

K162590 - Bashan TDP Heat Lamp

K162590 is an FDA 510(k) clearance for Bashan TDP Heat Lamp, manufactured by Chogqing Yuhe Medical Instruments Co., Ltd.. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K162590 · Chogqing Yuhe Medical Instruments Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2017
Decision
151d
Days
Class 2
Risk

K162590 is an FDA 510(k) clearance for the Bashan TDP Heat Lamp. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Chogqing Yuhe Medical Instruments Co., Ltd. (Chongqing, CN). The FDA issued a Cleared decision on February 14, 2017 after a review of 151 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Chogqing Yuhe Medical Instruments Co., Ltd. devices

FDA 510(k) Submission Details - K162590

510(k) Number K162590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2016
Decision Date February 14, 2017
Days to Decision 151 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
36d slower than avg
Panel avg: 115d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ILY Device Classification - Class 2, Special Controls

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 31
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