Cleared Traditional

K926250 - ELECTROMEDICS EL-SERIES CARDIOTOMY RESE...

K926250 is the FDA 510(k) clearance for ELECTROMEDICS EL-SERIES CARDIOTOMY RESE... by Electromedics, Inc.. It is a Class 2 Cardiovascular device (product code DTN) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K926250 · Electromedics, Inc. · Cardiovascular device
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Feb 1993
Decision
67d
Days
Class 2
Risk

K926250 is an FDA 510(k) clearance for the ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIR. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Electromedics, Inc. (Englewood, US). The FDA issued a Cleared decision on February 19, 1993 after a review of 67 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 K926250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1992
Decision Date February 19, 1993
Days to Decision 67 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 125d · This submission: 67d
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 K926250.
VENOUS RESERVIOR/CARDIOTOMY AUTOTRANSFUSION FILTER WITH DURAFLO II HEPARIN TREATMENT
K933713 · Baxter Healthcare Corp · Mar 1994
ATR-2900DF (WITH DEPTH FILTER)/CAP-35DF (WITH DEPTH FILTER)
K936286 · Gish Biomedical, Inc. · Feb 1994
BARD(R) BLOOD CARDIOPLEGIA HEAT EXCHANGER/TUBE SET
K930299 · C.R. Bard, Inc. · Jun 1993
VENOUS RESERVOIR W/CARDIOTOMY FILTER
K915573 · Baxter Healthcare Corp · Dec 1992
MVR COLLAPSIBLE VENOUS RESERVOIR BAG
K920774 · Medtronic Vascular · Oct 1992
MINIMAX (TM) COLLAPSIBLE VENOUS RESERVOIR BAG
K911790 · Medtronic Vascular · Aug 1991