Cleared Traditional

ATAD ARD CATHETER (K040625) - FDA 510(k) Clearance

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

K040625 · Atad Developments , Ltd. · Obstetrics & Gynecology device
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Jan 2005
Decision
315d
Days
Class 2
Risk

K040625 is an FDA 510(k) clearance for the ATAD ARD CATHETER. Classified as Dilator, Cervical, Hygroscopic-laminaria (product code HDY), Class II - Special Controls.

Submitted by Atad Developments , Ltd. (Haifa, IL). The FDA issued a Cleared decision on January 18, 2005 after a review of 315 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: Standard predicate-based submission. Elevated predicate reliance profile. 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.

View all Atad Developments , Ltd. devices

Submission Details

510(k) Number K040625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2004
Decision Date January 18, 2005
Days to Decision 315 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
155d slower than avg
Panel avg: 160d · This submission: 315d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HDY Dilator, Cervical, Hygroscopic-laminaria
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4260
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.