Cleared Traditional

K841913 - TEMPTREND PEDS AXILLARY TEMP. INDICATOR

K841913 is an FDA 510(k) clearance for TEMPTREND PEDS AXILLARY TEMP. INDICATOR, manufactured by Biosynergy, Inc.. The device is a Class 2 General Hospital device with product code KPD cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K841913 · Biosynergy, Inc. · General Hospital
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Nov 1984
Decision
177d
Days
Class 2
Risk

K841913 is an FDA 510(k) clearance for the TEMPTREND PEDS AXILLARY TEMP. INDICATOR. Classified as Strip, Temperature, Forehead, Liquid Crystal (product code KPD), Class II - Special Controls.

Submitted by Biosynergy, Inc. (Arlington Heights, US). The FDA issued a Cleared decision on November 2, 1984 after a review of 177 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2200 - 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 Biosynergy, Inc. devices

FDA 510(k) Submission Details - K841913

510(k) Number K841913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1984
Decision Date November 02, 1984
Days to Decision 177 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 129d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPD Device Classification - Class 2, Special Controls

Product Code KPD Strip, Temperature, Forehead, Liquid Crystal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2200
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 - KPD Strip, Temperature, Forehead, Liquid Crystal

Devices cleared under the same product code (KPD) and FDA review panel - the closest regulatory comparables to K841913.
TEMP MARQ TEMPERATURE TREND INDICATOR
K903307 · Marquest Medical Products, Inc. · Aug 1990
TEMPERATURE TREND INDICATOR (TTI)
K820426 · Mon-A-Therm, Inc. · Mar 1982
FEVER TESTER
K790532 · Maddak, Inc. · May 1979
TEMPERATURE INDICATOR
K780580 · Respiratory Care, Inc. · Apr 1978
TEMP. SENSOR W/22MM FITTINGS
K780260 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1978
ALARM, THERMAL, THERM-ALERT
K760683 · Respiratory Care, Inc. · Sep 1976