Cleared Traditional

K083131 - MEDOS HILITE RESERVOIR

K083131 is an FDA 510(k) clearance for MEDOS HILITE RESERVOIR, manufactured by Gish Biomedical, Inc.. The device is a Class 2 Cardiovascular device with product code DTN cleared through the Traditional 510(k) pathway after a 280-day FDA review.

K083131 · Gish Biomedical, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jul 2009
Decision
280d
Days
Class 2
Risk

K083131 is an FDA 510(k) clearance for the MEDOS HILITE RESERVOIR, MODEL: 4030. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Gish Biomedical, Inc. (Rancho Santa Margarita, US). The FDA issued a Cleared decision on July 30, 2009 after a review of 280 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4400 - 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 - K083131

510(k) Number K083131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2008
Decision Date July 30, 2009
Days to Decision 280 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
155d slower than avg
Panel avg: 125d · This submission: 280d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTN Device Classification - Class 2, Special Controls

Product Code DTN Reservoir, Blood, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4400
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 - DTN Reservoir, Blood, Cardiopulmonary Bypass

All 134
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K083131.
VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING
K090690 · Maquet Cardiopulmonary, AG · Dec 2009
SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR
K092315 · Sorin Group Italia S.R.L. · Aug 2009
MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730
K091062 · Gish Biomedical, Inc. · Aug 2009
GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING
K081947 · Gish Biomedical, Inc. · Feb 2009
GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING
K082082 · Gish Biomedical, Inc. · Feb 2009
JOSTRA VENOUS SOFTBAG RESERVOIRS WITH AND WITHOUT SAFELINE COATING
K070605 · Maquet Cardiopulmonary, AG · Jan 2008