Cleared Traditional

K811660 - PLAYTEX MODIFIED FIBER TAMPONS

K811660 is the FDA 510(k) clearance for PLAYTEX MODIFIED FIBER TAMPONS by Playtex, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HIL) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K811660 · Playtex, Inc. · Obstetrics & Gynecology device
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Jul 1981
Decision
34d
Days
Class 2
Risk

K811660 is an FDA 510(k) clearance for the PLAYTEX MODIFIED FIBER TAMPONS. Classified as Tampon, Menstrual, Scented, Scented-deodorized (product code HIL), Class II - Special Controls.

Submitted by Playtex, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 16, 1981 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5460 - 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 K811660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1981
Decision Date July 16, 1981
Days to Decision 34 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
126d faster than avg
Panel avg: 160d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HIL Tampon, Menstrual, Scented, Scented-deodorized
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5460
Definition A Scented Or Scented-deodorized 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 - HIL Tampon, Menstrual, Scented, Scented-deodorized

All 18
Devices cleared under the same product code (HIL) and FDA review panel - the closest regulatory comparables to K811660.
TAMPAX PETAL SOFT DEODORANT TAMPON, SUPER
K872259 · Tambrands, Inc. · Jul 1987
TAMPAX DEODORANT TAMPON, SLENDER REGULAR
K872260 · Tambrands, Inc. · Jul 1987
TAMPAX TAMPONS, VARIOUS SIZES/TYPES (MODIFICATION)
K862353 · Tambrands, Inc. · Jul 1986
RELY DEODERANT TAMPON
K800272 · Procter & Gamble Mfg. Co. · Feb 1980
STERILIZATION PROCESS/MATERNITY PAD
K792627 · Procter & Gamble Mfg. Co. · Jan 1980
TAMPON, HEAVY DUTY, & STICK
K780058 · Kimberly-Clark Corp. · Jan 1978