Cleared Traditional

K922933 - SORIN MONOLYRH INTEGRATED MEMBRANE LUNG

K922933 is an FDA 510(k) clearance for SORIN MONOLYRH INTEGRATED MEMBRANE LUNG, manufactured by Sorin Biomedica, Fiat, USA, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K922933

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
Combination Product No
PCCP Authorized No
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.

DTZ Device Classification - Class 2, Special Controls

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 220
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
SARNS SM03 MEMBRANE OXYGENATOR W/ INTEGRATED RESER
K912920 · 3M Health Care, Ltd. · Sep 1991