Cleared Special

K133261 - MEDOS HILITE 7000 & 7000 LT OXYGENATOR

K133261 is an FDA 510(k) clearance for MEDOS HILITE 7000 & 7000 LT OXYGENATOR, manufactured by Medos Medizintechnik AG. The device is a Class 2 Cardiovascular device with product code DTZ cleared through the Special 510(k) pathway after a 78-day FDA review.

K133261 · Medos Medizintechnik AG · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
78d
Days
Class 2
Risk

K133261 is an FDA 510(k) clearance for the MEDOS HILITE 7000 & 7000 LT OXYGENATOR. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Medos Medizintechnik AG (Ann Arbor, US). The FDA issued a Cleared decision on January 9, 2014 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4350 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K133261

510(k) Number K133261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2013
Decision Date January 09, 2014
Days to Decision 78 days
Submission Type Special
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
47d faster than avg
Panel avg: 125d · This submission: 78d
Pathway characteristics
Modification to existing cleared device.

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 247
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K133261.
TERUMO CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR
K140774 · Terumo Cardiovascular Systems Corporation · Jun 2014
MEDOS HILITE INFANT OXYGENATOR
K140181 · Medos Medizintechnik AG · Feb 2014
MEDOS HILITE OXYGENATOR
K140177 · Medos Medizintechnik AG · Feb 2014
QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS
K132829 · Maquet Cardiopulmonary, AG · Oct 2013
INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR, INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATE
K130433 · Sorin Group Italia S.R.L. · Mar 2013
CAPIOX FX HOLLOW FIBER OXYGENATOR W/ RESERVOIR
K130280 · Terumo Corporation · Mar 2013
K133261 · MEDOS HILITE 7000 & 7000 LT OXYGENATOR
Download PDF FDA Summary Medos Medizintechnik …