Cleared Traditional

K202433 - Aqueduct 200 Cervical Dilation Balloon Catheter (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K202433 · Gtimd, LLC · Obstetrics & Gynecology device
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Oct 2021
Decision
416d
Days
Class 2
Risk

K202433 is an FDA 510(k) clearance for the Aqueduct 200 Cervical Dilation Balloon Catheter. Classified as Catheter, Balloon, Dilation Of Cervical Canal (product code PON), Class II - Special Controls.

Submitted by Gtimd, LLC (Amherst, US). The FDA issued a Cleared decision on October 15, 2021 after a review of 416 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4260 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

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Submission Details

510(k) Number K202433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2020
Decision Date October 15, 2021
Days to Decision 416 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
256d slower than avg
Panel avg: 160d · This submission: 416d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PON Catheter, Balloon, Dilation Of Cervical Canal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4260
Definition Mechanical Dilation And Softening Of The Cervix.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.