Cleared Traditional

K945753 - FST FIBEROPTIC PRESSURE CONVERTER

K945753 is an FDA 510(k) clearance for FST FIBEROPTIC PRESSURE CONVERTER, manufactured by Fiberoptic Sensor Technlogies, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FEN cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K945753 · Fiberoptic Sensor Technlogies, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
169d
Days
Class 2
Risk

K945753 is an FDA 510(k) clearance for the FST FIBEROPTIC PRESSURE CONVERTER. Classified as Device, Cystometric, Hydraulic (product code FEN), Class II - Special Controls.

Submitted by Fiberoptic Sensor Technlogies, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on May 11, 1995 after a review of 169 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1620 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fiberoptic Sensor Technlogies, Inc. devices

FDA 510(k) Submission Details - K945753

510(k) Number K945753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1994
Decision Date May 11, 1995
Days to Decision 169 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
39d slower than avg
Panel avg: 130d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FEN Device Classification - Class 2, Special Controls

Product Code FEN Device, Cystometric, Hydraulic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1620
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 - FEN Device, Cystometric, Hydraulic

All 13
Devices cleared under the same product code (FEN) and FDA review panel - the closest regulatory comparables to K945753.
UROVISION JANUS
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K940203 · Life-Tech Intl., Inc. · Mar 1994
STAND ALONE CYSTOMETROGRAM
K934141 · Medical Engineering Corp. · Nov 1993