Cleared Traditional

K853843 - IV MATE

K853843 is an FDA 510(k) clearance for IV MATE, manufactured by Medtech Intl., Inc.. The device is a Class 2 General Hospital device with product code FLN cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K853843 · Medtech Intl., Inc. · General Hospital
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Jan 1986
Decision
115d
Days
Class 2
Risk

K853843 is an FDA 510(k) clearance for the IV MATE. Classified as Monitor, Electric For Gravity Flow Infusion Systems (product code FLN), Class II - Special Controls.

Submitted by Medtech Intl., Inc. (Apopka, US). The FDA issued a Cleared decision on January 9, 1986 after a review of 115 days - within the typical 510(k) review window.

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: 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 Medtech Intl., Inc. devices

FDA 510(k) Submission Details - K853843

510(k) Number K853843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1985
Decision Date January 09, 1986
Days to Decision 115 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 129d · This submission: 115d
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 21
Devices cleared under the same product code (FLN) and FDA review panel - the closest regulatory comparables to K853843.
FLUID CENTURION (4-100-00)
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TRAVENOL FLO-GARD 500 IV MONITOR
K850710 · Travenol Laboratories, S.A. · Apr 1985
DROP RATE COUNTER #340
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MODEL 460 INTERMITTENT MEDICATION DELIV
K823018 · Y · Jan 1983