Cleared Traditional

K813268 - SC-2500F CARDIOTOMY RESERVIOR

K813268 is an FDA 510(k) clearance for SC-2500F CARDIOTOMY RESERVIOR, 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 179-day FDA review.

K813268 · Scimed Life Systems, Inc. · Cardiovascular device
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May 1982
Decision
179d
Days
Class 2
Risk

K813268 is an FDA 510(k) clearance for the SC-2500F CARDIOTOMY RESERVIOR. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Scimed Life Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 18, 1982 after a review of 179 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 Scimed Life Systems, Inc. devices

FDA 510(k) Submission Details - K813268

510(k) Number K813268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1981
Decision Date May 18, 1982
Days to Decision 179 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
54d slower than avg
Panel avg: 125d · This submission: 179d
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 K813268.
VENOUS RESERVOIR BAG #BMR-1400
K823272 · Bentley Laboratories, Inc. · Dec 1982
EXV VENOUS RESERVOIR BAG & HOLDER
K823205 · Extracorporeal Medical Specialities, Inc. · Nov 1982
WILLIAM HARVEY FLEX. VENOUS RESERVOIR
K821442 · C.R. Bard, Inc. · Jun 1982
SUCKER CARDIOTOMY RETURN, C.P. BYPASS
K812455 · Electromedics, Inc. · Oct 1981
CORDIOTOMY RESERVOIR
K812008 · Bentley Laboratories, Inc. · Jul 1981
CARDIOTOMY RESERVOIR W/FILTER#BCR-3500
K812009 · Bentley Laboratories, Inc. · Jul 1981