Cleared Traditional

PULMOCATH INTRABRONCHIAL CATHETER (K901615) - FDA 510(k) Clearance

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

K901615 · Omnitron Intl., Inc. · Radiology device
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Nov 1992
Decision
966d
Days
Class 2
Risk

K901615 is an FDA 510(k) clearance for the PULMOCATH INTRABRONCHIAL CATHETER. Classified as System, Applicator, Radionuclide, Remote-controlled (product code JAQ), Class II - Special Controls.

Submitted by Omnitron Intl., Inc. (Lajke Charles, US). The FDA issued a Cleared decision on November 27, 1992 after a review of 966 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5700 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Omnitron Intl., Inc. devices

Submission Details

510(k) Number K901615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1990
Decision Date November 27, 1992
Days to Decision 966 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
859d slower than avg
Panel avg: 107d · This submission: 966d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAQ System, Applicator, Radionuclide, Remote-controlled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5700
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 Radiology devices follow this clearance model.

Regulatory Peers - JAQ System, Applicator, Radionuclide, Remote-controlled

All 69
Devices cleared under the same product code (JAQ) and FDA review panel - the closest regulatory comparables to K901615.
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