Cleared Traditional

K983478 - ORGANIC ESSENTIALS, ORGANIC COTTON TAMPON

K983478 is an FDA 510(k) clearance for ORGANIC ESSENTIALS, manufactured by Organic Essentials. The device is a Class 2 Obstetrics & Gynecology device with product code HEB cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K983478 · Organic Essentials · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
38d
Days
Class 2
Risk

K983478 is an FDA 510(k) clearance for the ORGANIC ESSENTIALS, ORGANIC COTTON TAMPON. Classified as Tampon, Menstrual, Unscented (product code HEB), Class II - Special Controls.

Submitted by Organic Essentials (O'Donnell, US). The FDA issued a Cleared decision on November 9, 1998 after a review of 38 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 Organic Essentials devices

FDA 510(k) Submission Details - K983478

510(k) Number K983478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1998
Decision Date November 09, 1998
Days to Decision 38 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 160d · This submission: 38d
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 136
Devices cleared under the same product code (HEB) and FDA review panel - the closest regulatory comparables to K983478.
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
O.B. APPLICATOR TAMPONS, O.B. TAMPONS
K991118 · Personal Products Co. · Jun 1999
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
PLAYTEX SILK GLIDE ODOR ABSORBING FLUSHABLE CARDBOARD TAMPONS #13598
K981760 · Playtime Products, Inc. · Jul 1998