Cleared Traditional

K962712 - YSANPOINT) (MENSTRUAL) DIGITAL TAMPON

K962712 is an FDA 510(k) clearance for YSANPOINT) (MENSTRUAL) DIGITAL TAMPON, manufactured by Talbot S. Lindstrom. The device is a Class 2 Obstetrics & Gynecology device with product code HEB cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K962712 · Talbot S. Lindstrom · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
60d
Days
Class 2
Risk

K962712 is an FDA 510(k) clearance for the YSANPOINT) (MENSTRUAL) DIGITAL TAMPON. Classified as Tampon, Menstrual, Unscented (product code HEB), Class II - Special Controls.

Submitted by Talbot S. Lindstrom (Stockholm, SE). The FDA issued a Cleared decision on September 10, 1996 after a review of 60 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 Talbot S. Lindstrom devices

FDA 510(k) Submission Details - K962712

510(k) Number K962712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1996
Decision Date September 10, 1996
Days to Decision 60 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
100d faster than avg
Panel avg: 160d · This submission: 60d
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 K962712.
ROSTAM APPLICATOR TAMPON/ROSTAM NON APPLICATOR TAMPON
K965064 · Rostam , Ltd. · Feb 1997
FEMTEX GENTLE TOUCH TAMPONS
K963034 · First Quality Hygienic, Inc. · Nov 1996
FREE CHOICE
K963032 · First Quality Hygienic, Inc. · Oct 1996
UNSCENTED MENSTRUAL TAMPON, PLASTIC APPLICATOR
K962476 · Tambrands, Inc. · Aug 1996
SANPOINT MENSTRUAL TAMPON
K961926 · Sanpoint AB · Jul 1996
TAMPAX TAMPON WITH ADDITIVE JUNIOR,REGULAR,SUPER, AND SUPER PLUS
K960341 · Tambrands, Inc. · Apr 1996