Cleared Traditional

K891366 - BIOSIGN BIOLOGICAL INDICATOR (EIGHT MONTH EXP.) (FDA 510(k) Clearance)

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

K891366 · Mdt Corp., Inc. · General Hospital
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Mar 1989
Decision
26d
Days
Class 2
Risk

K891366 is an FDA 510(k) clearance for the BIOSIGN BIOLOGICAL INDICATOR (EIGHT MONTH EXP.). Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Mdt Corp., Inc. (Rochester, US). The FDA issued a Cleared decision on March 29, 1989 after a review of 26 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 Mdt Corp., Inc. devices

Submission Details

510(k) Number K891366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1989
Decision Date March 29, 1989
Days to Decision 26 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
102d faster than avg
Panel avg: 128d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRC Indicator, Biological 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.

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