Cleared Special

K202427 - Aqueduct 100 Plus Cervical Dilation Balloon Catheter (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K202427 · Gtimd, LLC · Obstetrics & Gynecology device
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Nov 2020
Decision
73d
Days
Class 2
Risk

K202427 is an FDA 510(k) clearance for the Aqueduct 100 Plus 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 November 6, 2020 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4260 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Gtimd, LLC devices

Submission Details

510(k) Number K202427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2020
Decision Date November 06, 2020
Days to Decision 73 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 160d · This submission: 73d
Pathway characteristics
Modification to existing cleared device.

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.