Cleared Traditional

CARDIOTOMY RESERVOIR-FILTERED & NON (K830727) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K830727 · Electromics, Inc. · Cardiovascular device

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Apr 1983

Decision

28d

Days

Class 2

Risk

K830727 is an FDA 510(k) clearance for the CARDIOTOMY RESERVOIR-FILTERED & NON. Classified as Defoamer, Cardiopulmonary Bypass (product code DTP), Class II - Special Controls.

Submitted by Electromics, Inc. (Walker, US). The FDA issued a Cleared decision on April 5, 1983 after a review of 28 days - a notably fast clearance cycle.

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: 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 Electromics, Inc. devices

Submission Details

510(k) Number	K830727 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 08, 1983
Decision Date	April 05, 1983
Days to Decision	28 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

97d faster than avg

Panel avg: 125d · This submission: 28d

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 13

Devices cleared under the same product code (DTP) and FDA review panel - the closest regulatory comparables to K830727.

MCR4000 & MCR4000F CARDIOTOMY RESERVOIR

K902355 · Medtronic Vascular · Aug 1990

SHILEY 3L CARDIOTOMY RESERVOIR

K853503 · Shiley, Inc. · Nov 1985

SHILEY 3L CARDF PLUS

K832811 · Shiley, Inc. · Sep 1983

CARDF

K823731 · Shiley, Inc. · Jan 1983

CAPIOX CR-CARDIOTOMY RESERVOIR

K821538 · Terumo Medical Corp. · Aug 1982

CARDIOTOMY RESERVOIR WITH FILTER

K801360 · Travenol Laboratories, S.A. · Jul 1980

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K830727

Electromics, Inc.

Walker, MI · US

Regulatory profile

2 submissions 2 cleared

100% clearance rate · Active in Cardiovascular

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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