Cleared Traditional

K831458 - CARDIOPLEGIA RECIRCULATION SYS-BL 705/A

K831458 is an FDA 510(k) clearance for CARDIOPLEGIA RECIRCULATION SYS-BL 705/A, manufactured by Electromedics, Inc.. The device is a Class 2 Cardiovascular device with product code DWB cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K831458 · Electromedics, Inc. · Cardiovascular device
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Oct 1983
Decision
167d
Days
Class 2
Risk

K831458 is an FDA 510(k) clearance for the CARDIOPLEGIA RECIRCULATION SYS-BL 705/A. Classified as Pump, Blood, Cardiopulmonary Bypass, Roller Type (product code DWB), Class II - Special Controls.

Submitted by Electromedics, Inc. (Walker, US). The FDA issued a Cleared decision on October 20, 1983 after a review of 167 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4370 - 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 Electromedics, Inc. devices

FDA 510(k) Submission Details - K831458

510(k) Number K831458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1983
Decision Date October 20, 1983
Days to Decision 167 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
42d slower than avg
Panel avg: 125d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWB Device Classification - Class 2, Special Controls

Product Code DWB Pump, Blood, Cardiopulmonary Bypass, Roller Type
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4370
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 - DWB Pump, Blood, Cardiopulmonary Bypass, Roller Type

All 17
Devices cleared under the same product code (DWB) and FDA review panel - the closest regulatory comparables to K831458.
ANGIOMED INTRODUCING SETS
K874771 · Angiomed U.S., Inc. · Jan 1988
STOCKERT-SHILEY MULTIFLOW ROLLER PUMP MODULE
K861714 · Shiley, Inc. · Jul 1986
STOCKERT-SHILEY DOUBLE HEAD PUMP MODULE
K862116 · Shiley, Inc. · Jul 1986
SARNS PULSATILE PUMP
K820729 · 3M Health Care, Sarns · Nov 1982
PUMP MODULES PMO LO-110-PMD 10-210
K822071 · Gambro, Inc. · Aug 1982
COBE/STOCKERT BATTERY MODULE
K802714 · Cobe Laboratories, Inc. · Nov 1980