Cleared Traditional

K812618 - ASSURE NATURAL FIT TAMPON

K812618 is an FDA 510(k) clearance for ASSURE NATURAL FIT TAMPON, 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 17-day FDA review.

K812618 · Personal Products Co. · Obstetrics & Gynecology device
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Oct 1981
Decision
17d
Days
Class 2
Risk

K812618 is an FDA 510(k) clearance for the ASSURE NATURAL FIT TAMPON. 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 2, 1981 after a review of 17 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 - K812618

510(k) Number K812618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1981
Decision Date October 02, 1981
Days to Decision 17 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
143d faster than avg
Panel avg: 160d · This submission: 17d
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 K812618.
PLAYTEX SLENDER REGULAR TAMPONS
K841154 · Playtex, Inc. · Mar 1984
DEODORANT SLENDER REG. TAMPONS
K841155 · Playtex, Inc. · Mar 1984
PLAYTEX TAMPONS
K830966 · Playtex, Inc. · Apr 1983
IMPROVED PLAYTEX TAMPON
K812534 · Playtex, Inc. · Sep 1981
PLAYTEX COMBINATION FIBER MODIFIED TAMP
K811387 · Playtex, Inc. · Aug 1981
PLAYTEX COTTON TAMPONS
K811389 · Playtex, Inc. · Aug 1981