Cleared Traditional

K844803 - POLYESTER CARDIOTOMY RESERVOIR

K844803 is the FDA 510(k) clearance for POLYESTER CARDIOTOMY RESERVOIR by Electromedics, Inc.. It is a Class 2 Cardiovascular device (product code DTP) cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K844803 · Electromedics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1985
Decision
139d
Days
Class 2
Risk

K844803 is an FDA 510(k) clearance for the POLYESTER CARDIOTOMY RESERVOIR, FILTERED & UNFILTE. Classified as Defoamer, Cardiopulmonary Bypass (product code DTP), Class II - Special Controls.

Submitted by Electromedics, Inc. (Englewood, US). The FDA issued a Cleared decision on April 29, 1985 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4230 - 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.

View all Electromedics, Inc. devices

Submission Details

510(k) Number K844803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1984
Decision Date April 29, 1985
Days to Decision 139 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 125d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTP Defoamer, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4230
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 - DTP Defoamer, Cardiopulmonary Bypass

All 23
Devices cleared under the same product code (DTP) and FDA review panel - the closest regulatory comparables to K844803.
MODIFIED MODEL SC4000(F) CARDIOTOMY RESERVOIR
K855049 · Scimed Life Systems, Inc. · Feb 1986
SHILEY 3L CARDIOTOMY RESERVOIR
K853503 · Shiley, Inc. · Nov 1985
CARDIOTOMY RESERVOIR BRS-XXX & HOLDER BRS-HXX
K851004 · Gish Biomedical, Inc. · May 1985
SCIMED MODEL SC4000
K840610 · Scimed Life Systems, Inc. · Apr 1984
CARDIOTOMY RESERVOIR SC3500F
K834041 · Scimed Life Systems, Inc. · Jan 1984
SHILEY 3L CARDF PLUS
K832811 · Shiley, Inc. · Sep 1983