Cleared Traditional

K080775 - MAXIM PLASTIC APPLICATOR & NON-APPLICATOR TAMPONS

K080775 is an FDA 510(k) clearance for MAXIM PLASTIC APPLICATOR & NON-APPLICAT..., manufactured by Tosama D.D.. The device is a Class 2 Obstetrics & Gynecology device with product code HEB cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K080775 · Tosama D.D. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
175d
Days
Class 2
Risk

K080775 is an FDA 510(k) clearance for the MAXIM PLASTIC APPLICATOR & NON-APPLICATOR TAMPONS. Classified as Tampon, Menstrual, Unscented (product code HEB), Class II - Special Controls.

Submitted by Tosama D.D. (Vir, Domzale, SI). The FDA issued a Cleared decision on September 10, 2008 after a review of 175 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Tosama D.D. devices

FDA 510(k) Submission Details - K080775

510(k) Number K080775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2008
Decision Date September 10, 2008
Days to Decision 175 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 160d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 127
Devices cleared under the same product code (HEB) and FDA review panel - the closest regulatory comparables to K080775.
U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS
K112635 · Kimberly-Clark Corp. · Oct 2011
TAMPAX PEARL UNSCENTED TAMPONS, LIGHT, REGULAR, SUPER & SUPER PLUS, TAMPAX PEARL UNSCENTED TAMPONS, ULTRA
K091281 · Procter & Gamble Co. · Jun 2010
U BY KOTEX CLICK* UNSCENTED TAMPONS, MODEL ABSORBENCY: REGULAR, SUPER AND SUPER PLUS
K091749 · Kimberly-Clark Corp. · Dec 2009
TAMPAX COMPAK PEARL PLASTIC APPLICATOR SCENTED AND UNSCENTED TAMPONS
K062638 · Procter & Gamble Co. · Nov 2006
TAMPAX TAMPONS - (LIGHT,REGULAR,SUPER AND SUPER PLUS ABSORBENCIES)
K061486 · Procter & Gamble Co. · Aug 2006
TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, ULTRA ABSORBENCY (UNSCENTED AND SCENTED)
K051290 · Procter & Gamble Co. · Dec 2005