Cleared Traditional

K772358 - ETHYLENE OXIDE STERILI. INDICATOR

K772358 is the FDA 510(k) clearance for ETHYLENE OXIDE STERILI. INDICATOR by Bio-Medical Sciences, Inc.. It is a Class 2 General Hospital device (product code JOJ) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K772358 · Bio-Medical Sciences, Inc. · General Hospital
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Jan 1978
Decision
34d
Days
Class 2
Risk

K772358 is an FDA 510(k) clearance for the ETHYLENE OXIDE STERILI. INDICATOR. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Bio-Medical Sciences, Inc. (Walker, US). The FDA issued a Cleared decision on January 30, 1978 after a review of 34 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bio-Medical Sciences, Inc. devices

Submission Details

510(k) Number K772358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1977
Decision Date January 30, 1978
Days to Decision 34 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
95d faster than avg
Panel avg: 129d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOJ Indicator, Physical/chemical Sterilization Process
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2800
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.