Cleared Traditional

K913793 - SIMPEX INC. ORAL AND RECTAL THERMOMETERS (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K913793 · Simpex, Inc. · General Hospital
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Dec 1991
Decision
129d
Days
Class 2
Risk

K913793 is an FDA 510(k) clearance for the SIMPEX INC. ORAL AND RECTAL THERMOMETERS. Classified as Thermometer, Clinical Mercury (product code FLK), Class II - Special Controls.

Submitted by Simpex, Inc. (Jenkintown, US). The FDA issued a Cleared decision on December 30, 1991 after a review of 129 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2920 - 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 Simpex, Inc. devices

Submission Details

510(k) Number K913793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1991
Decision Date December 30, 1991
Days to Decision 129 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 128d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FLK Thermometer, Clinical Mercury
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2920
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.