Cleared Traditional

K090449 - MEDOS HILITE INFANT OXYGENATOR

K090449 is an FDA 510(k) clearance for MEDOS HILITE INFANT OXYGENATOR, manufactured by Gish Biomedical, Inc.. The device is a Class 2 Cardiovascular device with product code DTZ cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K090449 · Gish Biomedical, Inc. · Cardiovascular device
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Sep 2009
Decision
210d
Days
Class 2
Risk

K090449 is an FDA 510(k) clearance for the MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Gish Biomedical, Inc. (Rancho Santa Margarita, US). The FDA issued a Cleared decision on September 18, 2009 after a review of 210 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 Gish Biomedical, Inc. devices

FDA 510(k) Submission Details - K090449

510(k) Number K090449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2009
Decision Date September 18, 2009
Days to Decision 210 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
85d slower than avg
Panel avg: 125d · This submission: 210d
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 202
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K090449.
QUADROX-I SMALL ADULT MICROPOROUS MEMBRANE OXYGENATOR
K093522 · Maquet Cardiopulmonary, AG · Dec 2009
QUADROX-I SMALL ADULT WITH AND WITHOUT INTERGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODELS HMO 50000, HMO 51000
K090689 · Maquet Cardiopulmonary, AG · Oct 2009
APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
K092895 · Sorin Group Italia S.R.L. · Oct 2009
MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT
K090450 · Gish Biomedical, Inc. · Sep 2009
QUADROX-I ADULT MICROPOROUS MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BEHMO70000,BEQ-HMO70000
K090511 · Maquet Cardiopulmonary, AG · Jun 2009
MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LT
K082403 · Gish Biomedical, Inc. · May 2009