Cleared Traditional

K953638 - O.B. APPLICATOR TAMPONS

K953638 is an FDA 510(k) clearance for O.B. APPLICATOR TAMPONS, manufactured by Personal Products Co.. The device is a Class 2 Obstetrics & Gynecology device with product code HIL cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K953638 · Personal Products Co. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
77d
Days
Class 2
Risk

K953638 is an FDA 510(k) clearance for the O.B. APPLICATOR TAMPONS. Classified as Tampon, Menstrual, Scented, Scented-deodorized (product code HIL), Class II - Special Controls.

Submitted by Personal Products Co. (Milltown, US). The FDA issued a Cleared decision on October 20, 1995 after a review of 77 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 Personal Products Co. devices

FDA 510(k) Submission Details - K953638

510(k) Number K953638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1995
Decision Date October 20, 1995
Days to Decision 77 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
83d faster than avg
Panel avg: 160d · This submission: 77d
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 74
Devices cleared under the same product code (HIL) and FDA review panel - the closest regulatory comparables to K953638.
PLAYTEX TAMPONS GENTLE GLIDE DEORDORANT TAMPONS AND PLAYTEX/GENTLE GLIDE DEODORANT PORTABLES TAMPONS
K964269 · Playtime Products, Inc. · Nov 1996
PLAYTEX SLIMFIT TAMPONS
K961870 · Playtex Products, Inc. · Jun 1996
PLAYTEX TAMPONS #10296
K961456 · Playtime Products, Inc. · Jun 1996
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
PLATEX TAMPONS MODEL NUMBER 07094
K941196 · Playtex Family Products, Inc. · Apr 1994