Cleared Traditional

K130273 - PANPAC VAGINAL DILATORS (FDA 510(k) Clearance)

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

K130273 · Panpac Medical Corporation · Obstetrics & Gynecology device
Aug 2013
Decision
185d
Days
Class 2
Risk

K130273 is an FDA 510(k) clearance for the PANPAC VAGINAL DILATORS. Classified as Dilator, Vaginal (product code HDX), Class II - Special Controls.

Submitted by Panpac Medical Corporation (Shi-Chib District, Taipei Hsien, TW). The FDA issued a Cleared decision on August 8, 2013 after a review of 185 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.3900 - 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.

Submission Details

510(k) Number K130273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2013
Decision Date August 08, 2013
Days to Decision 185 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 158d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HDX Dilator, Vaginal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.3900
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.