Cleared Traditional

K850710 - TRAVENOL FLO-GARD 500 IV MONITOR

K850710 is an FDA 510(k) clearance for TRAVENOL FLO-GARD 500 IV MONITOR, 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 41-day FDA review.

K850710 · Travenol Laboratories, S.A. · General Hospital
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Apr 1985
Decision
41d
Days
Class 2
Risk

K850710 is an FDA 510(k) clearance for the TRAVENOL FLO-GARD 500 IV MONITOR. Classified as Monitor, Electric For Gravity Flow Infusion Systems (product code FLN), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Deerfield, US). The FDA issued a Cleared decision on April 4, 1985 after a review of 41 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 - K850710

510(k) Number K850710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1985
Decision Date April 04, 1985
Days to Decision 41 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
88d faster than avg
Panel avg: 129d · This submission: 41d
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 K850710.
IV MATE
K853843 · Medtech Intl., Inc. · Jan 1986
MCGAW/DROP WATCH FLOW MONITOR
K853549 · American Mcgaw · Nov 1985
INFUSAFE 205 CATOLOG NO. 205.000
K852433 · Medix Medical Electronics (U.S.A.), Inc. · Jun 1985
INFUSART
K844227 · Sartorius, Inc. · Jan 1985
IV RATEMETER
K844309 · Aci Medical, Inc. · Jan 1985
KHM 2000 DRIP WATCHER
K844556 · The Timeter Group · Jan 1985
K850710 · TRAVENOL FLO-GARD 500 IV MONITOR
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