Cleared Traditional

K780223 - PARENTERAL INFUSION CONTROLLER

K780223 is an FDA 510(k) clearance for PARENTERAL INFUSION CONTROLLER, manufactured by Travenol Laboratories, S.A.. The device is a Class 2 General Hospital device with product code FLN cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K780223 · Travenol Laboratories, S.A. · General Hospital
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Apr 1978
Decision
60d
Days
Class 2
Risk

K780223 is an FDA 510(k) clearance for the PARENTERAL INFUSION CONTROLLER. Classified as Monitor, Electric For Gravity Flow Infusion Systems (product code FLN), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Mchenry, US). The FDA issued a Cleared decision on April 10, 1978 after a review of 60 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2420 - 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.

FDA 510(k) Submission Details - K780223

510(k) Number K780223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1978
Decision Date April 10, 1978
Days to Decision 60 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
69d faster than avg
Panel avg: 129d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLN Device Classification - Class 2, Special Controls

Product Code FLN Monitor, Electric For Gravity Flow Infusion Systems
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2420
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 - FLN Monitor, Electric For Gravity Flow Infusion Systems

All 38
Devices cleared under the same product code (FLN) and FDA review panel - the closest regulatory comparables to K780223.
VOLUMETRIC CONTROLLER MODEL 310
K781589 · Imed Corp. · Nov 1978
MONITOR, GRAVITY IRRIGATION DRIP
K781717 · Syntel, Inc. · Oct 1978
INTRA-ALERT
K781297 · Pan-Tech Research, Inc. · Oct 1978
PARENTERAL INFUSION CONTROLLER, ELEC.
K780106 · National Patent Development Corp. · Feb 1978
I.V. DRIP MONITOR ALARM DEVICE, MONIFLO
K760931 · Diemolding Corp. · Jan 1977
ARNCO I.V. MONITOR
K760694 · A.R. Nelson Co., Inc. · Dec 1976
K780223 · PARENTERAL INFUSION CONTROLLER
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