Cleared Traditional

K833888 - PENASE

K833888 is the FDA 510(k) clearance for PENASE by Oxoid U.S.A., Inc.. It is a Class 1 Microbiology device (product code MDB) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K833888 · Oxoid U.S.A., Inc. · Microbiology device
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Jan 1984
Decision
55d
Days
Class 1
Risk

K833888 is an FDA 510(k) clearance for the PENASE. Classified as System, Blood Culturing (product code MDB), Class I - General Controls.

Submitted by Oxoid U.S.A., Inc. (Mchenry, US). The FDA issued a Cleared decision on January 3, 1984 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2560 - the FDA microbiology 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 Oxoid U.S.A., Inc. devices

Submission Details

510(k) Number K833888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1983
Decision Date January 03, 1984
Days to Decision 55 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 102d · This submission: 55d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MDB System, Blood Culturing
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2560
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - MDB System, Blood Culturing

All 56
Devices cleared under the same product code (MDB) and FDA review panel - the closest regulatory comparables to K833888.
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