Cleared Traditional

K812455 - SUCKER CARDIOTOMY RETURN

K812455 is the FDA 510(k) clearance for SUCKER CARDIOTOMY RETURN by Electromedics, Inc.. It is a Class 2 Cardiovascular device (product code DTN) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K812455 · Electromedics, Inc. · Cardiovascular device
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Oct 1981
Decision
56d
Days
Class 2
Risk

K812455 is an FDA 510(k) clearance for the SUCKER CARDIOTOMY RETURN, C.P. BYPASS. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Electromedics, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 23, 1981 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4400 - 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 Electromedics, Inc. devices

Submission Details

510(k) Number K812455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1981
Decision Date October 23, 1981
Days to Decision 56 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 125d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTN Reservoir, Blood, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4400
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 - DTN Reservoir, Blood, Cardiopulmonary Bypass

All 78
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K812455.
EXV VENOUS RESERVOIR BAG & HOLDER
K823205 · Extracorporeal Medical Specialities, Inc. · Nov 1982
WILLIAM HARVEY FLEX. VENOUS RESERVOIR
K821442 · C.R. Bard, Inc. · Jun 1982
SC-2500F CARDIOTOMY RESERVIOR
K813268 · Scimed Life Systems, Inc. · May 1982
INTERSEPT* VENOUS RESERVOIR BAG & HOLDER
K803059 · Extracorporeal Medical Specialities, Inc. · Dec 1980
SHILEY UTILITY RESERVOIR
K802119 · Shiley, Inc. · Sep 1980
DISPOSABLE CARDIOTOMY
K781577 · C.R. Bard, Inc. · Sep 1978