Cleared Traditional

K940319 - R-GROUP INTERNATIONAL COILED LOW PRESSURE EXTENSION LINE

K940319 is an FDA 510(k) clearance for R-GROUP INTERNATIONAL COILED LOW PRESSU..., manufactured by R-Group Intl.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 290-day FDA review.

K940319 · R-Group Intl. · General Hospital
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Nov 1994
Decision
290d
Days
Class 2
Risk

K940319 is an FDA 510(k) clearance for the R-GROUP INTERNATIONAL COILED LOW PRESSURE EXTENSION LINE. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by R-Group Intl. (Gainesville, US). The FDA issued a Cleared decision on November 10, 1994 after a review of 290 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all R-Group Intl. devices

FDA 510(k) Submission Details - K940319

510(k) Number K940319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1994
Decision Date November 10, 1994
Days to Decision 290 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
161d slower than avg
Panel avg: 129d · This submission: 290d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

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 General Hospital devices follow this clearance model.

Regulatory Peers - FPA Set, Administration, Intravascular

All 748
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