Cleared Traditional

K942418 - PLAYTEX TAMPONS MODEL 13794

K942418 is an FDA 510(k) clearance for PLAYTEX TAMPONS MODEL 13794, manufactured by Playtex, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HEB cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K942418 · Playtex, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
49d
Days
Class 2
Risk

K942418 is an FDA 510(k) clearance for the PLAYTEX TAMPONS MODEL 13794. Classified as Tampon, Menstrual, Unscented (product code HEB), Class II - Special Controls.

Submitted by Playtex, Inc. (Paramus, US). The FDA issued a Cleared decision on July 8, 1994 after a review of 49 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

FDA 510(k) Submission Details - K942418

510(k) Number K942418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1994
Decision Date July 08, 1994
Days to Decision 49 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
111d faster than avg
Panel avg: 160d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HEB Device Classification - Class 2, Special Controls

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 136
Devices cleared under the same product code (HEB) and FDA review panel - the closest regulatory comparables to K942418.
PLAYTEX ULTIMATES SILK GLIDE TAMPONS #22994
K944154 · Playtex Products, Inc. · Feb 1995
PLAYTEX ULTIMATES SILK GLIDE TAMPONS #23094
K944155 · Playtex Products, Inc. · Feb 1995
UNSCENTED MENSTRUAL TAMPONS
K944834 · Tambrands, Inc. · Dec 1994
O.B. TAMPON
K941863 · Personal Products Co. · Jun 1994
KOTEX DISCRETE DIGITAL TAMPONS, REG.,SUPER,SUPER+
K930149 · Kimberly-Clark Corp. · Mar 1994
TAMPAX TAMPONS, SUPER ABSORBENCY
K923932 · Tambrands, Inc. · Jul 1993