Cleared Traditional

K053025 - JOSTRA HLM TUBING SET

K053025 is the FDA 510(k) clearance for JOSTRA HLM TUBING SET by Maquet Cardiopulmonary, AG. It is a Class 2 Cardiovascular device (product code DWE) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K053025 · Maquet Cardiopulmonary, AG · Cardiovascular device
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Nov 2005
Decision
14d
Days
Class 2
Risk

K053025 is an FDA 510(k) clearance for the JOSTRA HLM TUBING SET. Classified as Tubing, Pump, Cardiopulmonary Bypass (product code DWE), Class II - Special Controls.

Submitted by Maquet Cardiopulmonary, AG (Fairfield, US). The FDA issued a Cleared decision on November 10, 2005 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4390 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Maquet Cardiopulmonary, AG devices

Submission Details

510(k) Number K053025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2005
Decision Date November 10, 2005
Days to Decision 14 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 125d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code DWE Tubing, Pump, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4390
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 Consultant

Intertek Testing Services
DANIEL W LEHTONEN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DWE Tubing, Pump, Cardiopulmonary Bypass

All 8
Devices cleared under the same product code (DWE) and FDA review panel - the closest regulatory comparables to K053025.
SMARxT Tubing and Connectors
K233702 · LivaNova USA, Inc. · Aug 2024
HLM TUBING SET WITH BIOLINE COATING
K080592 · Maquet Cardiopulmonary, AG · Sep 2008
PUMP TUBING
K013578 · Terumo Cardiovascular Systems Corp. · Jan 2002
COBE SMARXT TUBING AND CONNECTORS
K981613 · Cobe Cardiovascular, Inc. · Oct 1998
SARNS TEMPERATURE PROBE AND CONNECTOR
K905686 · 3M Health Care, Sarns · Feb 1991
SARNS EVACUPLEGE CATHETER
K842044 · 3M Health Care, Sarns · Aug 1984