Cleared Traditional

K143447 - Dilapan-S (FDA 510(k) Clearance)

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

K143447 · Medicem Technology S.R.O · Obstetrics & Gynecology device
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Apr 2015
Decision
136d
Days
Class 2
Risk

K143447 is an FDA 510(k) clearance for the Dilapan-S. Classified as Dilator, Cervical, Synthetic, Osmotic (product code PKN), Class II - Special Controls.

Submitted by Medicem Technology S.R.O (Kamenne Zehrovice, CZ). The FDA issued a Cleared decision on April 17, 2015 after a review of 136 days - within the typical 510(k) review window.

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: 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.

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Submission Details

510(k) Number K143447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2014
Decision Date April 17, 2015
Days to Decision 136 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 160d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PKN Dilator, Cervical, Synthetic, Osmotic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4260
Definition Cervical Softening And Dilation
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.