Cleared Traditional

K811385 - PLAYTEX DIGITAL TAMPON

K811385 is the FDA 510(k) clearance for PLAYTEX DIGITAL TAMPON by Playtex, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HEB) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K811385 · Playtex, Inc. · Obstetrics & Gynecology device
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Aug 1981
Decision
81d
Days
Class 2
Risk

K811385 is an FDA 510(k) clearance for the PLAYTEX DIGITAL TAMPON. Classified as Tampon, Menstrual, Unscented (product code HEB), Class II - Special Controls.

Submitted by Playtex, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 7, 1981 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5470 - 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 Playtex, Inc. devices

Submission Details

510(k) Number K811385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1981
Decision Date August 07, 1981
Days to Decision 81 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
79d faster than avg
Panel avg: 160d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HEB Tampon, Menstrual, Unscented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5470
Definition An Unscented Menstrual Tampon Is A Plug Made Of Cellulosic Or Synthetic Material That Is Inserted Into The Vagina And Used To Absorb Menstrual Fluid Or Other Vaginal Discharge.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HEB Tampon, Menstrual, Unscented

All 86
Devices cleared under the same product code (HEB) and FDA review panel - the closest regulatory comparables to K811385.
SUPER TAMPAX TAMPONS
K844936 · Tambrands, Inc. · Feb 1985
SUPER PETAL SOFT PLASTIC APPLICATOR TAMP
K842618 · Tambrands, Inc. · Jul 1984
REGULAR PETAL SOFT PLASTIC APPLICATOR
K842619 · Tambrands, Inc. · Jul 1984
JOHNSON & JOHNSON O.B. TAMPONS
K811983 · Johnson & Johnson Professionals, Inc. · Jul 1981
KOTEX SECURITY TUBE TAMPONS
K802193 · Kimberly-Clark Corp. · Nov 1980
RELY TAMPON
K791274 · Procter & Gamble Mfg. Co. · Aug 1979