Cleared Traditional

K250897 - Koala Intrauterine Pressure Catheter (I...

K250897 is an FDA 510(k) clearance for Koala Intrauterine Pressure Catheter (I..., manufactured by Clinical Innovations, LLC. The device is a Class 2 Obstetrics & Gynecology device with product code HFN cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K250897 · Clinical Innovations, LLC · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
May 2025
Decision
58d
Days
Class 2
Risk

K250897 is an FDA 510(k) clearance for the Koala Intrauterine Pressure Catheter (IPC-5000E). Classified as Transducer, Pressure, Intrauterine (product code HFN), Class II - Special Controls.

Submitted by Clinical Innovations, LLC (Murray, US). The FDA issued a Cleared decision on May 22, 2025 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2700 - 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 Clinical Innovations, LLC devices

FDA 510(k) Submission Details - K250897

510(k) Number K250897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2025
Decision Date May 22, 2025
Days to Decision 58 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 160d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HFN Device Classification - Class 2, Special Controls

Product Code HFN Transducer, Pressure, Intrauterine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2700
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.