Cleared Traditional

K031213 - AQUASENS FLUID MONITORING SYSTEM (FDA 510(k) Clearance)

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

K031213 · Davol, Inc. · Obstetrics & Gynecology device
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Apr 2003
Decision
13d
Days
Class 2
Risk

K031213 is an FDA 510(k) clearance for the AQUASENS FLUID MONITORING SYSTEM. Classified as Insufflator, Hysteroscopic (product code HIG), Class II - Special Controls.

Submitted by Davol, Inc. (Cranston, US). The FDA issued a Cleared decision on April 30, 2003 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1700 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Davol, Inc. devices

Submission Details

510(k) Number K031213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2003
Decision Date April 30, 2003
Days to Decision 13 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
147d faster than avg
Panel avg: 160d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code HIG Insufflator, Hysteroscopic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1700
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.