Cleared Traditional

K834152 - ETHYLENE OXIDE DETECTOR GLD-1-07

K834152 is an FDA 510(k) clearance for ETHYLENE OXIDE DETECTOR GLD-1-07, manufactured by Calnor of EL Paseo, Inc.. The device is a Class 2 General Hospital device with product code FLE cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K834152 · Calnor of EL Paseo, Inc. · General Hospital
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Mar 1984
Decision
109d
Days
Class 2
Risk

K834152 is an FDA 510(k) clearance for the ETHYLENE OXIDE DETECTOR GLD-1-07. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Calnor of EL Paseo, Inc. (Walker, US). The FDA issued a Cleared decision on March 19, 1984 after a review of 109 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6880 - 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 Calnor of EL Paseo, Inc. devices

FDA 510(k) Submission Details - K834152

510(k) Number K834152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1983
Decision Date March 19, 1984
Days to Decision 109 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
20d faster than avg
Panel avg: 129d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLE Device Classification - Class 2, Special Controls

Product Code FLE Sterilizer, Steam
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6880
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 - FLE Sterilizer, Steam

All 135
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K834152.
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MODIFIED CASTLE POWERCLAVE
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RITTER STERILIZER
K801309 · Sybron Corp. · Jun 1980
STERILIZING CASE CAT. NO. 65199
K800080 · Edward Weck, Inc. · Jan 1980
STERILIZER, EAGLE 2000
K781684 · American Sterilizer Co. · Oct 1978