Cleared Traditional

K941044 - PLAYTEX ULTIMATED TAMPONS MODEL NUMBER 06194

K941044 is an FDA 510(k) clearance for PLAYTEX ULTIMATED TAMPONS MODEL NUMBER ..., manufactured by Playtex, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIL cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K941044 · Playtex, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
142d
Days
Class 2
Risk

K941044 is an FDA 510(k) clearance for the PLAYTEX ULTIMATED TAMPONS MODEL NUMBER 06194. Classified as Tampon, Menstrual, Scented, Scented-deodorized (product code HIL), Class II - Special Controls.

Submitted by Playtex, Inc. (Paramus, US). The FDA issued a Cleared decision on July 27, 1994 after a review of 142 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, Inc. devices

FDA 510(k) Submission Details - K941044

510(k) Number K941044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1994
Decision Date July 27, 1994
Days to Decision 142 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
18d faster than avg
Panel avg: 160d · This submission: 142d
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 K941044.
PLAYTEX TAMPONS #10296
K961456 · Playtime Products, Inc. · Jun 1996
O.B. APPLICATOR TAMPONS
K953638 · Personal Products Co. · Oct 1995
SATIN TOUCH DEODORANT TAMPON JUNIOR, REGULAR, SUPER, SUPER PLUS
K952344 · Tambrands, Inc. · Jul 1995
PLATEX TAMPONS MODEL NUMBER 07094
K941196 · Playtex Family Products, Inc. · Apr 1994
PLAYTEX TAMPONS #04994 UNSCENTED & SCENTED
K940821 · Playtex Family Products, Inc. · Mar 1994
PLAYTEX ULTIMATES TAMPONS
K932907 · Playtex Family Products, Inc. · Mar 1994