Cleared Traditional

K901425 - PYLORIC BALLOON DILATOR

K901425 is an FDA 510(k) clearance for PYLORIC BALLOON DILATOR, manufactured by Telemed Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FAT cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K901425 · Telemed Systems, Inc. · Gastroenterology & Urology device
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Jun 1990
Decision
87d
Days
Class 2
Risk

K901425 is an FDA 510(k) clearance for the PYLORIC BALLOON DILATOR. Classified as Bougie, Esophageal, And Gastrointestinal, Gastro-urology (product code FAT), Class II - Special Controls.

Submitted by Telemed Systems, Inc. (Hudson, US). The FDA issued a Cleared decision on June 21, 1990 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5365 - 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 Telemed Systems, Inc. devices

FDA 510(k) Submission Details - K901425

510(k) Number K901425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1990
Decision Date June 21, 1990
Days to Decision 87 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 130d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FAT Device Classification - Class 2, Special Controls

Product Code FAT Bougie, Esophageal, And Gastrointestinal, Gastro-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5365
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 - FAT Bougie, Esophageal, And Gastrointestinal, Gastro-urology

Devices cleared under the same product code (FAT) and FDA review panel - the closest regulatory comparables to K901425.
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