Cleared Traditional

K863716 - RNET SYSTEM, IV RECEIVING TERMINAL, TRANSMITTER

K863716 · Futurecare Systems, Inc. · Cardiovascular device
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Dec 1986
Decision
90d
Days
-
Risk

K863716 is an FDA 510(k) clearance for the RNET SYSTEM, IV RECEIVING TERMINAL, TRANSMITTER.

Submitted by Futurecare Systems, Inc. (Findley, US). The FDA issued a Cleared decision on December 22, 1986 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel. 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Futurecare Systems, Inc. devices

FDA 510(k) Submission Details - K863716

510(k) Number K863716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1986
Decision Date December 22, 1986
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -