Cleared Traditional

K831692 - PRIVATE LABEL DEODORANT MINISHIELDS

K831692 · Int'L Consumer Disposables · Obstetrics & Gynecology device
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Jun 1983
Decision
23d
Days
-
Risk

K831692 is an FDA 510(k) clearance for the PRIVATE LABEL DEODORANT MINISHIELDS.

Submitted by Int'L Consumer Disposables (Mchenry, US). The FDA issued a Cleared decision on June 16, 1983 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology 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.

FDA 510(k) Submission Details - K831692

510(k) Number K831692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1983
Decision Date June 16, 1983
Days to Decision 23 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
138d faster than avg
Panel avg: 161d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -
K831692 · PRIVATE LABEL DEODORANT MINISHIELDS
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