Cleared Traditional

K991118 - O.B. APPLICATOR TAMPONS, O.B. TAMPONS

K991118 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 HEB cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K991118 · Personal Products Co. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
89d
Days
Class 2
Risk

K991118 is an FDA 510(k) clearance for the O.B. APPLICATOR TAMPONS, O.B. 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 June 29, 1999 after a review of 89 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

FDA 510(k) Submission Details - K991118

510(k) Number K991118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1999
Decision Date June 29, 1999
Days to Decision 89 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
71d faster than avg
Panel avg: 160d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HEB Device Classification - Class 2, Special Controls

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 153
Devices cleared under the same product code (HEB) and FDA review panel - the closest regulatory comparables to K991118.
TAMPAX SATIN TAMPONS, CLOSED END FLUSHABLE APPLICATOR
K002096 · Procter & Gamble Co. · Sep 2000
PLATEX ODER ABSORBING GENTLE GLIDE, SLIMFITS AND SILK GLIDE TAMPONS
K993794 · Playtime Products, Inc. · Feb 2000
O.B. TAMPON
K990536 · Personal Products Co. · Aug 1999
ORGANIC ESSENTIALS, ORGANIC COTTON TAMPON
K983478 · Organic Essentials · Nov 1998
VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS
K983381 · Paragon Trade Brands, Inc. · Oct 1998
VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS
K981953 · Paragon Trade Brands, Inc. · Aug 1998