Cleared Traditional

K063759 - HEATMARKER TIME TEMPERATURE INDICATOR

K063759 is an FDA 510(k) clearance for HEATMARKER TIME TEMPERATURE INDICATOR, manufactured by Temptime Corporation. The device is a Class 2 General Hospital device with product code OCI cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K063759 · Temptime Corporation · General Hospital
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Aug 2007
Decision
239d
Days
Class 2
Risk

K063759 is an FDA 510(k) clearance for the HEATMARKER TIME TEMPERATURE INDICATOR. Classified as Indicator, Physical/chemical, Storage Temperature (product code OCI), Class II - Special Controls.

Submitted by Temptime Corporation (Morris Plains, US). The FDA issued a Cleared decision on August 15, 2007 after a review of 239 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2800 - 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. Standard predicate reliance. 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 Temptime Corporation devices

FDA 510(k) Submission Details - K063759

510(k) Number K063759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2006
Decision Date August 15, 2007
Days to Decision 239 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
110d slower than avg
Panel avg: 129d · This submission: 239d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OCI Device Classification - Class 2, Special Controls

Product Code OCI Indicator, Physical/chemical, Storage Temperature
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2800
Definition The Time-temperature Indicator Provides A Visual Signal That A Selected Time-temperature Profile Has Been Exceeded. When Affixed To A Device, A Time Temperature Indicator Is Indicated, Via A Permanent Color Change, For The Purpose Of Distinguishing Between Medical Products That Have Exceeded A Selected Time-temperature Profile Of Interest To The User From Products That Have Not Exceeded That Profile.
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.