Cleared Traditional

K934941 - E-Z TEMP II

K934941 is an FDA 510(k) clearance for E-Z TEMP II, manufactured by Seven C'S, Inc.. The device is a Class 2 General Hospital device with product code KPD cleared through the Traditional 510(k) pathway after a 282-day FDA review.

K934941 · Seven C'S, Inc. · General Hospital
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Jul 1994
Decision
282d
Days
Class 2
Risk

K934941 is an FDA 510(k) clearance for the E-Z TEMP II. Classified as Strip, Temperature, Forehead, Liquid Crystal (product code KPD), Class II - Special Controls.

Submitted by Seven C'S, Inc. (St. Louis, US). The FDA issued a Cleared decision on July 27, 1994 after a review of 282 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 Seven C'S, Inc. devices

FDA 510(k) Submission Details - K934941

510(k) Number K934941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1993
Decision Date July 27, 1994
Days to Decision 282 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
153d slower than avg
Panel avg: 129d · This submission: 282d
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 K934941.
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