Cleared Traditional

K922601 - FUTREX-5000A

K922601 is the FDA 510(k) clearance for FUTREX-5000A by Futrex, Inc.. It is a Class 2 Cardiovascular device (product code DSB) cleared through the Traditional 510(k) pathway after a 1304-day FDA review.

K922601 · Futrex, Inc. · Cardiovascular device
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Dec 1995
Decision
1304d
Days
Class 2
Risk

K922601 is an FDA 510(k) clearance for the FUTREX-5000A. Classified as Plethysmograph, Impedance (product code DSB), Class II - Special Controls.

Submitted by Futrex, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on December 28, 1995 after a review of 1304 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2770 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Futrex, Inc. devices

Submission Details

510(k) Number K922601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1992
Decision Date December 28, 1995
Days to Decision 1304 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1179d slower than avg
Panel avg: 125d · This submission: 1304d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSB Plethysmograph, Impedance
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2770
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 Cardiovascular devices follow this clearance model.