Cleared Traditional

K841092 - HIGH PRESSURE FLEX. CONNECTING TUBING

K841092 is the FDA 510(k) clearance for HIGH PRESSURE FLEX. CONNECTING TUBING by Tronomed, Inc.. It is a Class 2 Cardiovascular device (product code DXT) cleared through the Traditional 510(k) pathway after a 498-day FDA review.

K841092 · Tronomed, Inc. · Cardiovascular device
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Jul 1985
Decision
498d
Days
Class 2
Risk

K841092 is an FDA 510(k) clearance for the HIGH PRESSURE FLEX. CONNECTING TUBING. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Tronomed, Inc. (Walker, US). The FDA issued a Cleared decision on July 24, 1985 after a review of 498 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - the FDA cardiovascular device 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 Cardiovascular submissions.

View all Tronomed, Inc. devices

Submission Details

510(k) Number K841092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1984
Decision Date July 24, 1985
Days to Decision 498 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
373d slower than avg
Panel avg: 125d · This submission: 498d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXT Injector And Syringe, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DXT Injector And Syringe, Angiographic

All 96
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K841092.
MECHANICAL INFLATION DEVICE
K862547 · American Edwards Laboratories · Sep 1986
ANGIOJECT
K860842 · Target Therapeutics · Apr 1986
ACS INDEFLATOR (MODIFICATION)
K854310 · Advanced Cardiovascular Systems, Inc. · Dec 1985
ADVANCED CARDIOVASCULAR SYSTEMS ANGIOJECT
K844045 · Advanced Cardiovascular Systems, Inc. · Nov 1984
CONTRAST MEDIA INJECT. SET CMS
K833645 · Gish Biomedical, Inc. · Apr 1984
ANGIOGRAPHIC DRAPE PACKS
K840281 · Medrad, Inc. · Apr 1984