Cleared Traditional

K902273 - O. B. PACK III (FDA 510(k) Clearance)

Class I Obstetrics & Gynecology device.

K902273 · Customed, Inc. · Obstetrics & Gynecology device
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Aug 1990
Decision
92d
Days
Class 1
Risk

K902273 is an FDA 510(k) clearance for the O. B. PACK III. Classified as Pad, Menstrual, Unscented (product code HHD), Class I - General Controls.

Submitted by Customed, Inc. (Carolina Puerto Rico, US). The FDA issued a Cleared decision on August 21, 1990 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5435 - the FDA obstetrics and gynecology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K902273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1990
Decision Date August 21, 1990
Days to Decision 92 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 160d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HHD Pad, Menstrual, Unscented
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.5435
Definition An Unscented Menstrual Pad Which Is Used To Absorb Menstrual Fluid Or Other Vaginal Discharge And Is Made Of Common Cellulosic And Synthetic Material With An Established Safety Profile.
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.