Cleared Traditional

K936189 - PLAYTEX ULTIMATES TAMPONS/UNSCENTED AND SCENTED

K936189 is an FDA 510(k) clearance for PLAYTEX ULTIMATES TAMPONS/UNSCENTED AND..., 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 70-day FDA review.

K936189 · Playtex Family Products, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
70d
Days
Class 2
Risk

K936189 is an FDA 510(k) clearance for the PLAYTEX ULTIMATES TAMPONS/UNSCENTED AND SCENTED. 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 March 7, 1994 after a review of 70 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 Family Products, Inc. devices

FDA 510(k) Submission Details - K936189

510(k) Number K936189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1993
Decision Date March 07, 1994
Days to Decision 70 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 160d · This submission: 70d
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 K936189.
PLAYTEX ULTIMATES TAMPONS
K932909 · Playtex Family Products, Inc. · Mar 1994
PLAYTEX ULTIMATES TAMPONS
K934083 · Playtex Family Products, Inc. · Mar 1994
PLAYTEX NON-DEODORANT TAMPONS, PLAYTEX DEODORANT TAMPONS
K935276 · 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 ULTIMATES UNSCENTED/SCENTED TAMPONS
K914438 · Playtex Family Products, Inc. · Jan 1992