Cleared Traditional

K945720 - JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE DEVICE

K945720 is an FDA 510(k) clearance for JOSTRA HL-15 MODULAR HEART-LUNG MACHINE..., manufactured by Jostra Bentley. The device is a Class 2 Cardiovascular device with product code DWC cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K945720 · Jostra Bentley · Cardiovascular device
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Mar 1995
Decision
128d
Days
Class 2
Risk

K945720 is an FDA 510(k) clearance for the JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE .... Classified as Controller, Temperature, Cardiopulmonary Bypass (product code DWC), Class II - Special Controls.

Submitted by Jostra Bentley (Austin, US). The FDA issued a Cleared decision on March 29, 1995 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4250 - 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.

FDA 510(k) Submission Details - K945720

510(k) Number K945720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1994
Decision Date March 29, 1995
Days to Decision 128 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 125d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWC Device Classification - Class 2, Special Controls

Product Code DWC Controller, Temperature, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4250
Definition If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - DWC Controller, Temperature, Cardiopulmonary Bypass

All 28
Devices cleared under the same product code (DWC) and FDA review panel - the closest regulatory comparables to K945720.
ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER
K014016 · Minntech Corp. · Feb 2002
ORIGEN BLADDER HOLDER
K003145 · Origen Biomedical, Inc. · Apr 2001
ALPHA OMEGA DUAL COOLER-HEATER
K001520 · Alpha Omega, Inc. · Nov 2000
CARDIAC COOLING JACKET, 8 CM, MODEL CJ-420
K896971 · Daily Medical Products, Inc. · Feb 1990
CARDIAC COOLING JACKET, 12 CM, MODEL CJ-520
K896972 · Daily Medical Products, Inc. · Feb 1990
CARDIAC COOLING JACKET, 30% ENLARGED, MODEL CJ-320
K896973 · Daily Medical Products, Inc. · Feb 1990
K945720 · JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE DEVICE
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