Cleared Abbreviated

K004001 - MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K004001 · Dideco · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
282d
Days
Class 2
Risk

K004001 is an FDA 510(k) clearance for the MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Dideco (Arvada, US). The FDA issued a Cleared decision on October 4, 2001 after a review of 282 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4350 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Dideco devices

Submission Details

510(k) Number K004001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2000
Decision Date October 04, 2001
Days to Decision 282 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
157d slower than avg
Panel avg: 125d · This submission: 282d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code DTZ Oxygenator, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4350
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 - DTZ Oxygenator, Cardiopulmonary Bypass

All 253
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K004001.
Lifemotion Disposable Membrane Oxygenator
K253838 · Lifemotion Medical Technology Co., Ltd. · Mar 2026
Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3)
K240934 · Spectrum Medical S.R.L. · Mar 2026
Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300)
K250821 · Eurosets S.R.L · Dec 2025
Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)
K242503 · Eurosets S.R.L · Nov 2025
Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2
K231982 · Qura S.R.L · Sep 2024
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811)
K240666 · Medtronic Perfusion Systems · Jul 2024