Cleared Traditional

K922933 - SORIN MONOLYRH INTEGRATED MEMBRANE LUNG

K922933 is the FDA 510(k) clearance for SORIN MONOLYRH INTEGRATED MEMBRANE LUNG by Sorin Biomedica, Fiat, USA, Inc.. It is a Class 2 Cardiovascular device (product code DTZ) cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K922933 · Sorin Biomedica, Fiat, USA, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1992
Decision
165d
Days
Class 2
Risk

K922933 is an FDA 510(k) clearance for the SORIN MONOLYRH INTEGRATED MEMBRANE LUNG. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Sorin Biomedica, Fiat, USA, Inc. (Irvine, US). The FDA issued a Cleared decision on November 30, 1992 after a review of 165 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 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 Sorin Biomedica, Fiat, USA, Inc. devices

Submission Details

510(k) Number K922933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1992
Decision Date November 30, 1992
Days to Decision 165 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
40d slower than avg
Panel avg: 125d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 120
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K922933.
SARNS TURBO MEMBRANE OXYGENA. W/INT. CARDIOTOMY R.
K925076 · 3M Health Care, Sarns · Jun 1993
COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR
K923272 · Cobe Laboratories, Inc. · May 1993
MAXIMA PLUS HOLLOW FIBER OXYGENATOR
K925626 · Medtronic Vascular · Feb 1993
MINIMAX(R)/MAXIMA(R) HOLLOW FIBER OXYGENATORS
K920889 · Medtronic Vascular · Sep 1992
SARNS SMOC MEMBRANE OXY W/INTEGRAT CARD RES,MODIFY
K912079 · 3M Health Care, Sarns · Oct 1991
MINIMAX OXYGENATION SYSTEM
K912655 · Medtronic Vascular · Sep 1991