Cleared Traditional

K974629 - O.B. APPLICATOR AND NON-APPLICATOR TAMPONS

K974629 is the FDA 510(k) clearance for O.B. APPLICATOR AND NON-APPLICATOR TAMPONS by Personal Products Co.. It is a Class 2 Obstetrics & Gynecology device (product code HEB) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K974629 · Personal Products Co. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
60d
Days
Class 2
Risk

K974629 is an FDA 510(k) clearance for the O.B. APPLICATOR AND NON-APPLICATOR TAMPONS. Classified as Tampon, Menstrual, Unscented (product code HEB), Class II - Special Controls.

Submitted by Personal Products Co. (Skillman, US). The FDA issued a Cleared decision on February 10, 1998 after a review of 60 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 Personal Products Co. devices

Submission Details

510(k) Number K974629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1997
Decision Date February 10, 1998
Days to Decision 60 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
100d faster than avg
Panel avg: 160d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 99
Devices cleared under the same product code (HEB) and FDA review panel - the closest regulatory comparables to K974629.
U BY KOTEX CLICK* UNSCENTED TAMPONS, MODEL ABSORBENCY: REGULAR, SUPER AND SUPER PLUS
K091749 · Kimberly-Clark Corp. · Dec 2009
O.B. TAMPON
K990536 · Personal Products Co. · Aug 1999
O.B. APPLICATOR TAMPONS, O.B. TAMPONS
K991118 · Personal Products Co. · Jun 1999
O.B. APPLICATOR TAMPONS
K970954 · Personal Products Co. · Jun 1997
UNSCENTED MENSTRUAL TAMPON, PLASTIC APPLICATOR
K962476 · Tambrands, Inc. · Aug 1996
TAMPAX TAMPON WITH ADDITIVE JUNIOR,REGULAR,SUPER, AND SUPER PLUS
K960341 · Tambrands, Inc. · Apr 1996