Cleared Traditional

INOCULUM STDIZING SYS., INOCUPAC (K781097) - FDA 510(k) Clearance

K781097 · 3M Company · Microbiology device
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Aug 1978
Decision
42d
Days
-
Risk

K781097 is an FDA 510(k) clearance for the INOCULUM STDIZING SYS., INOCUPAC.

Submitted by 3M Company (White City, US). The FDA issued a Cleared decision on August 14, 1978 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel. 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.

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Submission Details

510(k) Number K781097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1978
Decision Date August 14, 1978
Days to Decision 42 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
60d faster than avg
Panel avg: 102d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -