Cleared Traditional

PROMISE ABSORBENT PROTECTIVE PAD (K900421) - FDA 510(k) Clearance

Class I Obstetrics & Gynecology device.

K900421 · Scott Health Care · Obstetrics & Gynecology device
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Jun 1990
Decision
127d
Days
Class 1
Risk

K900421 is an FDA 510(k) clearance for the PROMISE ABSORBENT PROTECTIVE PAD. Classified as Pad, Menstrual, Unscented (product code HHD), Class I - General Controls.

Submitted by Scott Health Care (Philadelphia, US). The FDA issued a Cleared decision on June 6, 1990 after a review of 127 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 K900421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1990
Decision Date June 06, 1990
Days to Decision 127 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
33d faster than avg
Panel avg: 160d · This submission: 127d
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.