Cleared Traditional

K812659 - TERUMO HOLLOW OXYGENATOR CIRCUIT

K812659 is an FDA 510(k) clearance for TERUMO HOLLOW OXYGENATOR CIRCUIT, manufactured by Terumo Medical Corp.. The device is a Class 2 Cardiovascular device with product code DTM cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K812659 · Terumo Medical Corp. · Cardiovascular device
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Dec 1981
Decision
87d
Days
Class 2
Risk

K812659 is an FDA 510(k) clearance for the TERUMO HOLLOW OXYGENATOR CIRCUIT. Classified as Filter, Blood, Cardiopulmonary Bypass, Arterial Line (product code DTM), Class II - Special Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on December 14, 1981 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4260 - 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 Terumo Medical Corp. devices

FDA 510(k) Submission Details - K812659

510(k) Number K812659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1981
Decision Date December 14, 1981
Days to Decision 87 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 125d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTM Device Classification - Class 2, Special Controls

Product Code DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4260
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 - DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line

All 73
Devices cleared under the same product code (DTM) and FDA review panel - the closest regulatory comparables to K812659.
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K820679 · Bentley Laboratories, Inc. · Jun 1982
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K820472 · C.R. Bard, Inc. · Mar 1982
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K820045 · Bentley Laboratories, Inc. · Jan 1982
SHILEY ARTERIAL FILTER W/40 MICRON SCREE
K812742 · Shiley, Inc. · Nov 1981
SHILEY ARTERIAL FILTER
K811379 · Shiley, Inc. · Jun 1981
PEDIATRIC ARTERIAL BLOOD FILTER
K810068 · Delta Medical Industries · Jan 1981