Cleared Traditional

K954445 - NON APPLICATOR TAMPON

K954445 is an FDA 510(k) clearance for NON APPLICATOR TAMPON, manufactured by Hygieia Healthcare , Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HEB cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K954445 · Hygieia Healthcare , Ltd. · Obstetrics & Gynecology device
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Feb 1996
Decision
140d
Days
Class 2
Risk

K954445 is an FDA 510(k) clearance for the NON APPLICATOR TAMPON, UNTREATED. Classified as Tampon, Menstrual, Unscented (product code HEB), Class II - Special Controls.

Submitted by Hygieia Healthcare , Ltd. (Castletown, Sunderland Sr5 3rx, GB). The FDA issued a Cleared decision on February 12, 1996 after a review of 140 days - within the typical 510(k) review window.

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 Hygieia Healthcare , Ltd. devices

FDA 510(k) Submission Details - K954445

510(k) Number K954445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1995
Decision Date February 12, 1996
Days to Decision 140 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 160d · This submission: 140d
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 107
Devices cleared under the same product code (HEB) and FDA review panel - the closest regulatory comparables to K954445.
O.B. APPLICATOR TAMPONS
K970954 · Personal Products Co. · Jun 1997
UNSCENTED MENSTRUAL TAMPON, PLASTIC APPLICATOR
K962476 · Tambrands, Inc. · Aug 1996
TAMPAX TAMPON WITH ADDITIVE JUNIOR,REGULAR,SUPER, AND SUPER PLUS
K960341 · Tambrands, Inc. · Apr 1996
UNSCENTED MENSTRUAL TAMPONS
K944834 · Tambrands, Inc. · Dec 1994
O.B. TAMPON
K941863 · Personal Products Co. · Jun 1994
KOTEX DISCRETE DIGITAL TAMPONS, REG.,SUPER,SUPER+
K930149 · Kimberly-Clark Corp. · Mar 1994