Cleared Traditional

K792538 - CONTINU-FLO ADMIN. SET CODE 2C/200

K792538 is an FDA 510(k) clearance for CONTINU-FLO ADMIN. SET CODE 2C/200, manufactured by Travenol Laboratories, S.A.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K792538 · Travenol Laboratories, S.A. · General Hospital
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Dec 1979
Decision
10d
Days
Class 2
Risk

K792538 is an FDA 510(k) clearance for the CONTINU-FLO ADMIN. SET CODE 2C/200. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Mchenry, US). The FDA issued a Cleared decision on December 20, 1979 after a review of 10 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

FDA 510(k) Submission Details - K792538

510(k) Number K792538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1979
Decision Date December 20, 1979
Days to Decision 10 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
119d faster than avg
Panel avg: 129d · This submission: 10d
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 772
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K792538.
LOW PLASTICIZER ADMINISTRATION SETS
K791496 · Travenol Laboratories, S.A. · Apr 1980
PRI. PIGGYBACK I.V. W/DUAL PIERCING PIN
K800137 · Abbott Laboratories · Mar 1980
VENTED I.V. SET
K792228 · Abbott Laboratories · Jan 1980
ALBUMIN INTRAVENOUS ADMINISTRATION SET
K791672 · Delmed, Inc. · Oct 1979
IV EXTENSION SET SL
K791930 · Abbott Laboratories · Oct 1979
SURFLO INJECTION PLUG
K791173 · Terumo America, Inc. · Jul 1979