Cleared Traditional

K897012 - SCENTED OR SCENTED DEODORIZED, UNSCENTED TAMPONS

K897012 is an FDA 510(k) clearance for SCENTED OR SCENTED DEODORIZED, 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 2-day FDA review.

K897012 · Playtex Family Products, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1989
Decision
2d
Days
Class 2
Risk

K897012 is an FDA 510(k) clearance for the SCENTED OR SCENTED DEODORIZED, UNSCENTED TAMPONS. 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 December 22, 1989 after a review of 2 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 - K897012

510(k) Number K897012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1989
Decision Date December 22, 1989
Days to Decision 2 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
158d faster than avg
Panel avg: 160d · This submission: 2d
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 K897012.
PLAYTEX ULTIMATES UNSCENTED/SCENTED TAMPONS
K914438 · Playtex Family Products, Inc. · Jan 1992
PLAYTEX NON-DEODORANT/DEODORANT TAMPONS
K912002 · Playtex Family Products, Inc. · Aug 1991
PLAYTEX NON-DEODORANT AND DEODORANT TAMPONS
K905378 · Playtex Family Products, Inc. · Feb 1991
TAMPON, PETAL SOFT PLASTIC APPLI., DEODORANT SUPER
K896115 · Tambrands, Inc. · Dec 1989
PLAYTEX PORTABLES NON-DEODORANT & DOED. TAMPONS
K891297 · Playtex Family Products, Inc. · Jun 1989
PLAYTEX NON-DEODORANT AND DEODORANT TAMPONS
K884737 · Playtex Family Products, Inc. · Jan 1989