Cleared Traditional

K972964 - ATRION MEDICAL BALLOON CATHETER INFLATI...

K972964 is an FDA 510(k) clearance for ATRION MEDICAL BALLOON CATHETER INFLATI..., manufactured by Atrion Medical Products, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KOE cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K972964 · Atrion Medical Products, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
60d
Days
Class 2
Risk

K972964 is an FDA 510(k) clearance for the ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE. Classified as Dilator, Urethral (product code KOE), Class II - Special Controls.

Submitted by Atrion Medical Products, Inc. (Arab, US). The FDA issued a Cleared decision on October 10, 1997 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5520 - the FDA gastroenterology and urology 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 Atrion Medical Products, Inc. devices

FDA 510(k) Submission Details - K972964

510(k) Number K972964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1997
Decision Date October 10, 1997
Days to Decision 60 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 130d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOE Device Classification - Class 2, Special Controls

Product Code KOE Dilator, Urethral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5520
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KOE Dilator, Urethral

All 15
Devices cleared under the same product code (KOE) and FDA review panel - the closest regulatory comparables to K972964.
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AMS OPTILUME INFLATION SYRINGE
K900760 · American Medical Systems, Inc. · May 1990