Cleared Traditional

CAPIOX CR-CARDIOTOMY RESERVOIR (K821538) - FDA 510(k) Clearance

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

K821538 · Terumo Medical Corp. · Cardiovascular device

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Aug 1982

Decision

74d

Days

Class 2

Risk

K821538 is an FDA 510(k) clearance for the CAPIOX CR-CARDIOTOMY RESERVOIR. Classified as Defoamer, Cardiopulmonary Bypass (product code DTP), Class II - Special Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on August 6, 1982 after a review of 74 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 Terumo Medical Corp. devices

Submission Details

510(k) Number	K821538 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 24, 1982
Decision Date	August 06, 1982
Days to Decision	74 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

51d faster than avg

Panel avg: 125d · This submission: 74d

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 16

Devices cleared under the same product code (DTP) and FDA review panel - the closest regulatory comparables to K821538.

CARDIOTOMY RESERVOIR SC3500F

K834041 · Scimed Life Systems, Inc. · Jan 1984

SHILEY 3L CARDF PLUS

K832811 · Shiley, Inc. · Sep 1983

CARDF

K823731 · Shiley, Inc. · Jan 1983

SCIMED MODEL SC 3000

K820954 · Scimed Life Systems, Inc. · May 1982

CARDIOTOMY RESERVOIR WITH FILTER

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

SHILEY CARDIOTOMY RESERVOIR W/FILTER

K801375 · Shiley, Inc. · 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 K821538

Terumo Medical Corp.

Elkton, MD · US

Regulatory profile

143 submissions 143 cleared

100% clearance rate · Active in Cardiovascular

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

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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