Cleared Traditional

DISPOSABLE LYMPHANGIOGRAM SET (K781575) - FDA 510(k) Clearance

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

K781575 · Instranetics, Inc. · Radiology device
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Dec 1978
Decision
81d
Days
Class 2
Risk

K781575 is an FDA 510(k) clearance for the DISPOSABLE LYMPHANGIOGRAM SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Instranetics, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 4, 1978 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 880.5440 - 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: 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 Instranetics, Inc. devices

Submission Details

510(k) Number K781575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1978
Decision Date December 04, 1978
Days to Decision 81 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 107d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

All 238
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K781575.
SOLUTION ADMINISTRATION, TIP PROTECTOR
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FILTER FOR HYPERALIMENTATION SET
K782134 · Travenol Laboratories, S.A. · Jan 1979
SOLUTION ADMINISTRATION, FLEX VALVE
K781812 · Travenol Laboratories, S.A. · Dec 1978
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K781036 · Baxter Healthcare Corp · Aug 1978
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K780970 · Travenol Laboratories, S.A. · Jul 1978
I.V. LEVER CLAMP
K780481 · Travenol Laboratories, S.A. · Apr 1978