Cleared Traditional

K914438 - PLAYTEX ULTIMATES UNSCENTED/SCENTED TAMPONS

K914438 is an FDA 510(k) clearance for PLAYTEX ULTIMATES UNSCENTED/SCENTED TAMPONS, manufactured by Playtex Family Products, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIL cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K914438 · Playtex Family Products, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Jan 1992
Decision
90d
Days
Class 2
Risk

K914438 is an FDA 510(k) clearance for the PLAYTEX ULTIMATES UNSCENTED/SCENTED TAMPONS. Classified as Tampon, Menstrual, Scented, Scented-deodorized (product code HIL), Class II - Special Controls.

Submitted by Playtex Family Products, Inc. (Paramus, US). The FDA issued a Cleared decision on January 2, 1992 after a review of 90 days - within the typical 510(k) review window.

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: 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.

View all Playtex Family Products, Inc. devices

FDA 510(k) Submission Details - K914438

510(k) Number K914438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1991
Decision Date January 02, 1992
Days to Decision 90 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 160d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIL Device Classification - Class 2, Special Controls

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 68
Devices cleared under the same product code (HIL) and FDA review panel - the closest regulatory comparables to K914438.
PLAYTEX ULTIMATES TAMPONS/UNSCENTED AND SCENTED
K936189 · Playtex Family Products, Inc. · Mar 1994
TAMPONS, NATURAL ODOR PROT. VARIOUS ABSORBENCY
K922834 · Playtex Family Products, Inc. · Sep 1993
PLAYTEX FLUSHABLE TAMPONS, REGULAR, SUPER, SUPER +
K924279 · Playtex Family Products, Inc. · May 1993
PLAYTEX NON-DEODORANT/DEODORANT TAMPONS
K912002 · Playtex Family Products, Inc. · Aug 1991
PLAYTEX NON-DEODORANT AND DEODORANT TAMPONS
K905378 · Playtex Family Products, Inc. · Feb 1991
SCENTED OR SCENTED DEODORIZED, UNSCENTED TAMPONS
K897012 · Playtex Family Products, Inc. · Dec 1989