Cleared Traditional

K831667 - FEMININE HYGIENE DEVICE

K831667 is an FDA 510(k) clearance for FEMININE HYGIENE DEVICE, manufactured by Snow Willow Co.. The device is a Class 1 Obstetrics & Gynecology device with product code HED cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K831667 · Snow Willow Co. · Obstetrics & Gynecology device
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Sep 1983
Decision
112d
Days
Class 1
Risk

K831667 is an FDA 510(k) clearance for the FEMININE HYGIENE DEVICE. Classified as Douche Apparatus, Vaginal, Therapeutic (product code HED), Class I - General Controls.

Submitted by Snow Willow Co. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1983 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5900 - 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 - K831667

510(k) Number K831667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1983
Decision Date September 12, 1983
Days to Decision 112 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 161d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

HED Device Classification - Class 1, General Controls

Product Code HED Douche Apparatus, Vaginal, Therapeutic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.5900
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 - HED Douche Apparatus, Vaginal, Therapeutic

All 10
Devices cleared under the same product code (HED) and FDA review panel - the closest regulatory comparables to K831667.
GENT-L-KARE VAGINAL IRRIGATION SET
K881216 · Geneva Laboratories, Inc. · Jun 1988
P.A. MEDICAL VAGINAL IRRIGATION SET #1130
K854595 · Pa Medical Corp. · Jan 1986
MAC LEE VAGINAL IRRIGATOR
K841710 · Mac Lee Medical Products · Jun 1984
DOUCHE TRAY-DISPOS. VAGINAL TRAY W/POVID
K800954 · The Healthcare Group Laboratories, Inc. · Oct 1980
DOUCH TRAY-DISPOSABLE VAGINAL TRAY W/BEN
K800956 · The Healthcare Group Laboratories, Inc. · Oct 1980
DOUCHE UNIT-1500 ML DISP. CONTAINER
K800957 · The Healthcare Group Laboratories, Inc. · Jul 1980
K831667 · FEMININE HYGIENE DEVICE
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