Cleared Traditional

K951693 - CARESS SANITARY NAPKIN

K951693 is an FDA 510(k) clearance for CARESS SANITARY NAPKIN, manufactured by Sterling U.S.A., Inc.. The device is a Class 1 Obstetrics & Gynecology device with product code HHD cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K951693 · Sterling U.S.A., Inc. · Obstetrics & Gynecology device
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Jul 1995
Decision
104d
Days
Class 1
Risk

K951693 is an FDA 510(k) clearance for the CARESS SANITARY NAPKIN. Classified as Pad, Menstrual, Unscented (product code HHD), Class I - General Controls.

Submitted by Sterling U.S.A., Inc. (Bristol, US). The FDA issued a Cleared decision on July 25, 1995 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5435 - 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 Sterling U.S.A., Inc. devices

FDA 510(k) Submission Details - K951693

510(k) Number K951693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1995
Decision Date July 25, 1995
Days to Decision 104 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
56d faster than avg
Panel avg: 160d · This submission: 104d
Pathway characteristics
Predicate-based equivalence.

HHD Device Classification - Class 1, General Controls

Product Code HHD Pad, Menstrual, Unscented
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.5435
Definition An Unscented Menstrual Pad Which Is Used To Absorb Menstrual Fluid Or Other Vaginal Discharge And Is Made Of Common Cellulosic And Synthetic Material With An Established Safety Profile.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HHD Pad, Menstrual, Unscented

All 64
Devices cleared under the same product code (HHD) and FDA review panel - the closest regulatory comparables to K951693.
ENVIVE MINIFORMS
K003843 · Procter & Gamble Co. · Feb 2001
UNSCENTED INTERLABIAL MENSTRUAL PAD
K993870 · Procter & Gamble Co. · Jan 2000
GLADRAGS COTTON MENSTRUAL PAD
K980395 · Keepers!, Inc. · Apr 1998
KOTEX(R) SECUREHOLD SUPER CURVE/CURVED MAXI PADS
K925250 · Kimberly-Clark Corp. · Mar 1993
ALWAYS CONTOURS UNSCENTED MENSTRUAL PADS
K922575 · Procter & Gamble Co. · Feb 1993
NEW FREEDOM ULTRA THIN PADS
K920830 · Kimberly-Clark Corp. · Sep 1992