Cleared Traditional

DOUCHE KIT, SOMETHING PERSONAL (K781207) - FDA 510(k) Clearance

Class I Obstetrics & Gynecology device.

K781207 · Chatten Drug & Chemical Co. · Obstetrics & Gynecology device
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Aug 1978
Decision
27d
Days
Class 1
Risk

K781207 is an FDA 510(k) clearance for the DOUCHE KIT, SOMETHING PERSONAL. Classified as Douche Apparatus, Vaginal, Therapeutic (product code HED), Class I - General Controls.

Submitted by Chatten Drug & Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on August 10, 1978 after a review of 27 days - a notably fast clearance 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: 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 Chatten Drug & Chemical Co. devices

Submission Details

510(k) Number K781207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1978
Decision Date August 10, 1978
Days to Decision 27 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
133d faster than avg
Panel avg: 160d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.