Cleared Traditional

PLAYTEX SLENDER REGULAR TAMPONS (K841154) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K841154 · Playtex, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1984
Decision
-
Days
Class 2
Risk

K841154 is an FDA 510(k) clearance for the PLAYTEX SLENDER REGULAR TAMPONS. Classified as Tampon, Menstrual, Scented, Scented-deodorized (product code HIL), Class II - Special Controls.

Submitted by Playtex, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 19, 1984.

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

Submission Details

510(k) Number K841154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received March 19, 1984
Decision Date March 19, 1984
Days to Decision -
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.