Tool · 510(k)

510(k) Predicate Finder

Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

Product Code: HHD FDA class 1

Pad, Menstrual, Unscented

Obstetrics/Gynecology

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The Unscented Menstrual Pad is an external absorbent product worn against the body to collect menstrual fluid during menstruation, without added fragrances or deodorizing agents. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from 510(k) premarket notification. The product code is HHD, regulated under 21 CFR 884.5435, within the Obstetrics/Gynecology specialty. No special risk flags apply.

510(k) Clearances

50+ matches
K Number
Device Name
ALWAYS MENSTRUAL PADS
ALWAYS DUETS
ENVIVE MINIFORMS
UNSCENTED INTERLABIAL MENSTRUAL PAD
GLADRAGS COTTON MENSTRUAL PAD
FLUSHIES FLUSHABLE/BIODEGRADABLE MENSTRUAL PADS/NAPKINS (ULTRA THINS)
UNSCENTED ULTRATHIN MAXI PAD
UNSCENTED CURVED ULTRATHIN MAXI PADS
UNSCENTED MENSTRUAL PAD
UNSCENTED MENSTRAL PAD
UNSCENTED MENSTRUAL PAD
UNSCENTED MENSTRAL PAD WITH WINGS
UNSCENTED CURVED MAXI PAD
UNSCENTED MENSTRUAL LINER
UNSCENTED MENSTRUAL SHIELD
CARESS SANITARY NAPKIN
REUSABLE MENSTRUAL PAD
SELF SUPER MAXI SNAITARY NAPKINS
FEMININE MAXI PADS
OPTIONS COMFORT CURVES CLOTH MENSTRUAL PAD SYSTEM
NATRACARE MENSTRUAL PADS
LADY'S CARE MAXI PADS
PANTY LINERS
UNSCENTED MENSTRUAL PAD TIER-1 REVIEW
PADS MENSTRUAL, UNTREAT DEODORIZED, VARIOUS SIZES
UNSCENTED MENSTRUAL PAD
SABA INTIMA
CONFORT
SABA CONFORT
ULTRA THIN MENSTRUAL PAD
KOTEX(R) SECUREHOLD SUPER CURVE/CURVED MAXI PADS
ALWAYS CONTOURS UNSCENTED MENSTRUAL PADS
NEW FREEDOM ULTRA THIN PADS
STAYFREE(TM) MAXI-PAD
DELUXE SANITARY PAD
O. B. PACK III
WHENEVER(R) UNSCENTED SUPER MAXI PAD
SABA CONFORT MENSTRUAL PAD
O. B. PACK II
O. B. PACK I
CAREFREE(TM) FESTIVA PANTYSHIELDS
PROMISE ABSORBENT PROTECTIVE PAD
SURE & NATURAL(TM) UNSCENTED MENSTRUAL PAD
NEW FREEDOM ANYDAY PANTILINERS
LAURIER SANITARY NAPKIN
SANITARY NAPKIN PADS
TAMPAX ULTRAFIT PANTY SHIELDS - MOFIFICATION
NEW FREEDOM THIN SUPER & UNSCENTED, MAXI & SUPER
TAMPAX ULTRAFIT PANTY SHIELDS
ALWAYS UNSCENTED MENSTRUAL PADS

What is a Predicate Device?

A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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