Cleared Traditional

K843595 - CARDIOTOMY RESERVOIR W/FILTER

K843595 is the FDA 510(k) clearance for CARDIOTOMY RESERVOIR W/FILTER by Omnis Surgical, Inc.. It is a Class 2 Cardiovascular device (product code DTN) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K843595 · Omnis Surgical, Inc. · Cardiovascular device
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Feb 1985
Decision
155d
Days
Class 2
Risk

K843595 is an FDA 510(k) clearance for the CARDIOTOMY RESERVOIR W/FILTER. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Omnis Surgical, Inc. (Deerfield, US). The FDA issued a Cleared decision on February 14, 1985 after a review of 155 days - an extended review 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: 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 Omnis Surgical, Inc. devices

Submission Details

510(k) Number K843595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1984
Decision Date February 14, 1985
Days to Decision 155 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 125d · This submission: 155d
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 K843595.
BARD WILLIAM HARVEY CARDIOTOMY RESERVOIR
K862920 · C.R. Bard, Inc. · Sep 1986
MODIFIED CARDIOTOMY RESERVOIR 5M1470
K862357 · 3M Health Care, Sarns · Aug 1986
SHILEY VENOUS RESERVOIR
K854841 · Shiley, Inc. · Feb 1986
CARDIOTOMY RESERVOIR BRS-XXX SERIES &
K843888 · Gish Biomedical, Inc. · Feb 1985
SHILEY HARDSHELL VENOUS RESERVOIR W/INT
K843232 · Shiley, Inc. · Jan 1985
VENOUS RESERVOIR VRS-XXX SERIES
K844229 · Gish Biomedical, Inc. · Jan 1985