Cleared Traditional

K760694 - ARNCO I.V. MONITOR

K760694 is an FDA 510(k) clearance for ARNCO I.V. MONITOR, manufactured by A.R. Nelson Co., Inc.. The device is a Class 2 General Hospital device with product code FLN cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K760694 · A.R. Nelson Co., Inc. · General Hospital
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Dec 1976
Decision
92d
Days
Class 2
Risk

K760694 is an FDA 510(k) clearance for the ARNCO I.V. MONITOR. Classified as Monitor, Electric For Gravity Flow Infusion Systems (product code FLN), Class II - Special Controls.

Submitted by A.R. Nelson Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on December 23, 1976 after a review of 92 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 A.R. Nelson Co., Inc. devices

FDA 510(k) Submission Details - K760694

510(k) Number K760694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1976
Decision Date December 23, 1976
Days to Decision 92 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
37d faster than avg
Panel avg: 129d · This submission: 92d
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.