Cleared Traditional

K950194 - TAMPON, UNTREATED

K950194 is an FDA 510(k) clearance for 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 219-day FDA review.

K950194 · Hygieia Healthcare , Ltd. · Obstetrics & Gynecology device
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Aug 1995
Decision
219d
Days
Class 2
Risk

K950194 is an FDA 510(k) clearance for the 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 August 25, 1995 after a review of 219 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.

FDA 510(k) Submission Details - K950194

510(k) Number K950194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1995
Decision Date August 25, 1995
Days to Decision 219 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
58d slower than avg
Panel avg: 161d · This submission: 219d
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 171
Devices cleared under the same product code (HEB) and FDA review panel - the closest regulatory comparables to K950194.
TAMPAX TAMPON WITH ADDITIVE JUNIOR,REGULAR,SUPER, AND SUPER PLUS
K960341 · Tambrands, Inc. · Apr 1996
NON APPLICATOR TAMPON, UNTREATED
K954445 · Hygieia Healthcare , Ltd. · Feb 1996
NATRACAREN APPLICATOR TAMPON
K954942 · Bodywise (Uk), Ltd. · Jan 1996
PLAYTEX ULTIMATES SILK GLIDE TAMPONS #22894
K944064 · Playtex, Inc. · Feb 1995
PLAYTEX ULTIMATES SILK GLIDE TAMPONS #22994
K944154 · Playtex Products, Inc. · Feb 1995
PLAYTEX ULTIMATES SILK GLIDE TAMPONS #23094
K944155 · Playtex Products, Inc. · Feb 1995