Cleared Traditional

K882380 - SCIMED MODEL SM-C/VR CARDIOTOMY/VENOUS RESERVOIR

K882380 is an FDA 510(k) clearance for SCIMED MODEL SM-C/VR CARDIOTOMY/VENOUS ..., manufactured by Scimed Life Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DTN cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K882380 · Scimed Life Systems, Inc. · Cardiovascular device
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Oct 1988
Decision
119d
Days
Class 2
Risk

K882380 is an FDA 510(k) clearance for the SCIMED MODEL SM-C/VR CARDIOTOMY/VENOUS RESERVOIR. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Scimed Life Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on October 6, 1988 after a review of 119 days - within the typical 510(k) review window.

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 Scimed Life Systems, Inc. devices

FDA 510(k) Submission Details - K882380

510(k) Number K882380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1988
Decision Date October 06, 1988
Days to Decision 119 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
6d faster than avg
Panel avg: 125d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTN Device Classification - Class 2, Special Controls

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 147
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K882380.
DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR
K884872 · Shiley, Inc. · Jan 1989
BLOOD RESERVOIR, CARDIOPULMONARY BYPASS
K882414 · Gish Biomedical, Inc. · Dec 1988
CARDIOTOMY/VENOUS RESERVOIR NO.: CVR SERIES
K883923 · Gish Biomedical, Inc. · Nov 1988
SARNS INFANT VENOUS RESERVOIR MODEL #16387
K883345 · 3M Health Care, Sarns · Sep 1988
SCIMED R30 SILICONE ASSIST RESERVOIR
K882720 · Scimed Life Systems, Inc. · Sep 1988
MAXIMA* COLLAPSIBLE VENOUS RESERVOIR BAG & HOLDER
K873423 · Johnson & Johnson Professionals, Inc. · Nov 1987