Cleared Traditional

K954942 - NATRACAREN APPLICATOR TAMPON

K954942 is an FDA 510(k) clearance for NATRACAREN APPLICATOR TAMPON, manufactured by Bodywise (Uk), Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HEB cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K954942 · Bodywise (Uk), Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
87d
Days
Class 2
Risk

K954942 is an FDA 510(k) clearance for the NATRACAREN APPLICATOR TAMPON. Classified as Tampon, Menstrual, Unscented (product code HEB), Class II - Special Controls.

Submitted by Bodywise (Uk), Ltd. (Bristol, Avon, GB). The FDA issued a Cleared decision on January 25, 1996 after a review of 87 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 Bodywise (Uk), Ltd. devices

FDA 510(k) Submission Details - K954942

510(k) Number K954942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1995
Decision Date January 25, 1996
Days to Decision 87 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 160d · This submission: 87d
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 K954942.
SANPOINT MENSTRUAL TAMPON
K961926 · Sanpoint AB · Jul 1996
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
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