Cleared Traditional

K812243 - INTERFACE CARDIOTOMY BLOOD FILTER #51

K812243 is an FDA 510(k) clearance for INTERFACE CARDIOTOMY BLOOD FILTER #51, manufactured by Medical, Inc.. The device is a Class 2 Cardiovascular device with product code JOD cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K812243 · Medical, Inc. · Cardiovascular device
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Aug 1981
Decision
14d
Days
Class 2
Risk

K812243 is an FDA 510(k) clearance for the INTERFACE CARDIOTOMY BLOOD FILTER #51. Classified as Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass (product code JOD), Class II - Special Controls.

Submitted by Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 25, 1981 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4270 - 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 Medical, Inc. devices

FDA 510(k) Submission Details - K812243

510(k) Number K812243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1981
Decision Date August 25, 1981
Days to Decision 14 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
111d faster than avg
Panel avg: 125d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOD Device Classification - Class 2, Special Controls

Product Code JOD Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4270
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 - JOD Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass

All 9
Devices cleared under the same product code (JOD) and FDA review panel - the closest regulatory comparables to K812243.
CARDIOTOMY FILTER
K830634 · Texas Medical Products, Inc. · Jun 1983
INTERFACE CARDIOTOMY BLOOD FILTER #50
K823259 · Medical, Inc. · Nov 1982
INTERFACE CARDIOTOMY BLOOD FILTER #51
K823260 · Medical, Inc. · Nov 1982
INTERFACE CARDIOTOMY BLOOD FILTER
K781383 · Medical, Inc. · Sep 1978
EXTRACORPEAL CARDIOTOMY BLOOD FILTER
K780653 · Cobe Laboratories, Inc. · Jun 1978