Cleared Traditional

K800954 - DOUCHE TRAY-DISPOS. VAGINAL TRAY W/POVID

K800954 is an FDA 510(k) clearance for DOUCHE TRAY-DISPOS. VAGINAL TRAY W/POVID, manufactured by The Healthcare Group Laboratories, Inc.. The device is a Class 1 Obstetrics & Gynecology device with product code HED cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K800954 · The Healthcare Group Laboratories, Inc. · Obstetrics & Gynecology device
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Oct 1980
Decision
163d
Days
Class 1
Risk

K800954 is an FDA 510(k) clearance for the DOUCHE TRAY-DISPOS. VAGINAL TRAY W/POVID. Classified as Douche Apparatus, Vaginal, Therapeutic (product code HED), Class I - General Controls.

Submitted by The Healthcare Group Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 3, 1980 after a review of 163 days - an extended review cycle.

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.

View all The Healthcare Group Laboratories, Inc. devices

FDA 510(k) Submission Details - K800954

510(k) Number K800954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1980
Decision Date October 03, 1980
Days to Decision 163 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
3d slower than avg
Panel avg: 160d · This submission: 163d
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.