Cleared Traditional

K941196 - PLATEX TAMPONS MODEL NUMBER 07094

K941196 is an FDA 510(k) clearance for PLATEX TAMPONS MODEL NUMBER 07094, 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 36-day FDA review.

K941196 · Playtex Family Products, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
36d
Days
Class 2
Risk

K941196 is an FDA 510(k) clearance for the PLATEX TAMPONS MODEL NUMBER 07094. 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 April 19, 1994 after a review of 36 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 - K941196

510(k) Number K941196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1994
Decision Date April 19, 1994
Days to Decision 36 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
124d faster than avg
Panel avg: 160d · This submission: 36d
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 K941196.
O.B. APPLICATOR TAMPONS
K953638 · Personal Products Co. · Oct 1995
SATIN TOUCH DEODORANT TAMPON JUNIOR, REGULAR, SUPER, SUPER PLUS
K952344 · Tambrands, Inc. · Jul 1995
PLAYTEX ULTIMATED TAMPONS MODEL NUMBER 06194
K941044 · Playtex, Inc. · Jul 1994
PLAYTEX TAMPONS #04994 UNSCENTED & SCENTED
K940821 · Playtex Family Products, Inc. · Mar 1994
PLAYTEX ULTIMATES TAMPONS
K932907 · Playtex Family Products, Inc. · Mar 1994
PLAYTEX ULTIMATES TAMPONS
K932909 · Playtex Family Products, Inc. · Mar 1994