Cleared Traditional

K850061 - MICRO VOLUME DOUBLE LINE EXTENSION SET

K850061 is the FDA 510(k) clearance for MICRO VOLUME DOUBLE LINE EXTENSION SET by Travenol Laboratories, S.A.. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K850061 · Travenol Laboratories, S.A. · General Hospital
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Mar 1985
Decision
78d
Days
Class 2
Risk

K850061 is an FDA 510(k) clearance for the MICRO VOLUME DOUBLE LINE EXTENSION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Hooksett, US). The FDA issued a Cleared decision on March 27, 1985 after a review of 78 days - a notably fast clearance 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: 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 Travenol Laboratories, S.A. devices

Submission Details

510(k) Number K850061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1985
Decision Date March 27, 1985
Days to Decision 78 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 129d · This submission: 78d
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 General Hospital devices follow this clearance model.

Regulatory Peers - FPA Set, Administration, Intravascular

All 448
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K850061.
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CRITIKON I.V. ADMINISTRAION SET
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K844937 · Y · Jan 1985
ANTI-ASPIRATION VALVE
K843748 · Travenol Laboratories, S.A. · Jan 1985