Cleared Traditional

LUNAPADS (K010986) - FDA 510(k) Clearance

Class I Obstetrics & Gynecology device.

K010986 · Lunapads International Products, Ltd. · Obstetrics & Gynecology device
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Jun 2001
Decision
72d
Days
Class 1
Risk

K010986 is an FDA 510(k) clearance for the LUNAPADS. Classified as Pad, Menstrual, Reusable (product code NUQ), Class I - General Controls.

Submitted by Lunapads International Products, Ltd. (Vancouver Bc, CA). The FDA issued a Cleared decision on June 13, 2001 after a review of 72 days - a notably fast clearance cycle.

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: 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 Lunapads International Products, Ltd. devices

Submission Details

510(k) Number K010986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2001
Decision Date June 13, 2001
Days to Decision 72 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 160d · This submission: 72d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NUQ Pad, Menstrual, Reusable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.5435
Definition A Reusable, Unscented Menstrual Pad Which Is Used To Absorb Menstrual Fluid Or Other Vaginal Discharge And Is Made Of Common Cellulosic Or 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.