Cleared Traditional

K843388 - WELLINGTON HOSPITAL PATTERN SELF-RETAIN (FDA 510(k) Clearance)

Class I Obstetrics & Gynecology device.

K843388 · Downs Surgical , Ltd. · Obstetrics & Gynecology device
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Oct 1984
Decision
33d
Days
Class 1
Risk

K843388 is an FDA 510(k) clearance for the WELLINGTON HOSPITAL PATTERN SELF-RETAIN. Classified as Speculum, Vaginal, Metal (product code HDF), Class I - General Controls.

Submitted by Downs Surgical , Ltd. (Mchenry, US). The FDA issued a Cleared decision on October 1, 1984 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4520 - 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 Downs Surgical , Ltd. devices

Submission Details

510(k) Number K843388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1984
Decision Date October 01, 1984
Days to Decision 33 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
127d faster than avg
Panel avg: 160d · This submission: 33d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HDF Speculum, Vaginal, Metal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.4520
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.