Cleared Traditional

K922601 - FUTREX-5000A

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

K922601 · Futrex, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K922601

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
Combination Product No
PCCP Authorized No
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.

DSB Device Classification - Class 2, Special Controls

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.

Regulatory Peers - DSB Plethysmograph, Impedance

All 114
Devices cleared under the same product code (DSB) and FDA review panel - the closest regulatory comparables to K922601.
BIOZ SYSTEM
K963183 · Cardiodynamics International Corp. · Nov 1996
NICAS 2001 NONINVASIVE CARDIO-RESPIRATORY SYSTEM
K942227 · C.L. Mcintosh & Assoc., Inc. · Jun 1996
FUTREX-5000
K922600 · Futrex, Inc. · Dec 1995
BODYSTAY
K951097 · Bodystat , Ltd. · Nov 1995
SORBA MODEL CIC-1000 NON-INVASIVE HEMODYNAMIC MONITOR
K950389 · Sorba Medical Systems, Inc. · Aug 1995
HYPERGRAPH
K941162 · Dermed Diagnostics, Inc. · Dec 1994
K922601 · FUTREX-5000A
Download PDF FDA Summary Futrex, Inc.