Cleared Traditional

K800272 - RELY DEODERANT TAMPON

K800272 is the FDA 510(k) clearance for RELY DEODERANT TAMPON by Procter & Gamble Mfg. Co.. It is a Class 2 Obstetrics & Gynecology device (product code HIL) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K800272 · Procter & Gamble Mfg. Co. · Obstetrics & Gynecology device
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Feb 1980
Decision
19d
Days
Class 2
Risk

K800272 is an FDA 510(k) clearance for the RELY DEODERANT TAMPON. Classified as Tampon, Menstrual, Scented, Scented-deodorized (product code HIL), Class II - Special Controls.

Submitted by Procter & Gamble Mfg. Co. (Mchenry, US). The FDA issued a Cleared decision on February 26, 1980 after a review of 19 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 Procter & Gamble Mfg. Co. devices

Submission Details

510(k) Number K800272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1980
Decision Date February 26, 1980
Days to Decision 19 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
141d faster than avg
Panel avg: 160d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 23
Devices cleared under the same product code (HIL) and FDA review panel - the closest regulatory comparables to K800272.
TAMPAX TAMPONS, VARIOUS SIZES/TYPES (MODIFICATION)
K862353 · Tambrands, Inc. · Jul 1986
ASSURE NATURAL FIT TAMPON
K812618 · Personal Products Co. · Oct 1981
ASSURE NATURAL FIT TAMPON
K811214 · Personal Products Co. · May 1981
STERILIZATION PROCESS/MATERNITY PAD
K792627 · Procter & Gamble Mfg. Co. · Jan 1980
ASSURE NATURAL FIT TAMPON
K781085 · Personal Products Co. · Jul 1978
TAMPON, HEAVY DUTY, & STICK
K780058 · Kimberly-Clark Corp. · Jan 1978