Cleared Traditional

K012974 - PRIZM MEDICAL INC. THERMOTRACE INFRARED...

K012974 is the FDA 510(k) clearance for PRIZM MEDICAL INC. THERMOTRACE INFRARED... by Prizm Medical, Inc.. It is a Class 2 General Hospital device (product code FLL) cleared through the Traditional 510(k) pathway after a 321-day FDA review.

K012974 · Prizm Medical, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Jul 2002
Decision
321d
Days
Class 2
Risk

K012974 is an FDA 510(k) clearance for the PRIZM MEDICAL INC. THERMOTRACE INFRARED THERMOMETER MODELS 15004 AND 15007. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Prizm Medical, Inc. (Dunwoody, US). The FDA issued a Cleared decision on July 23, 2002 after a review of 321 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2910 - 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 Prizm Medical, Inc. devices

Submission Details

510(k) Number K012974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2001
Decision Date July 23, 2002
Days to Decision 321 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
192d slower than avg
Panel avg: 129d · This submission: 321d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FLL Continuous Measurement Thermometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2910
Definition A Continuous Measurement Thermometer Is A Clinical Electronic Thermometer Indicated To Measure The Body Or Skin Temperature Of A Person Continuously Or In Specified Intervals. Under This Regulation, This Product Code Represents Non-exempt Devices. For More Information, See 90 Fr 25889, Available At Https://www.govinfo.gov/content/pkg/fr-2025-06-18/pdf/2025-11207.pdf.
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 General Hospital devices follow this clearance model.

Regulatory Peers - FLL Continuous Measurement Thermometer

All 248
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K012974.
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