Cleared Traditional

K960916 - SAMS 8000 CARDIOPLEGIA MONITOR

K960916 is an FDA 510(k) clearance for SAMS 8000 CARDIOPLEGIA MONITOR, manufactured by 3M Health Care, Sarns. The device is a Class 2 Cardiovascular device with product code DSJ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K960916 · 3M Health Care, Sarns · Cardiovascular device
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Jun 1996
Decision
90d
Days
Class 2
Risk

K960916 is an FDA 510(k) clearance for the SAMS 8000 CARDIOPLEGIA MONITOR. Classified as Alarm, Blood-pressure (product code DSJ), Class II - Special Controls.

Submitted by 3M Health Care, Sarns (Ann Arbor, US). The FDA issued a Cleared decision on June 4, 1996 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1100 - 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 3M Health Care, Sarns devices

FDA 510(k) Submission Details - K960916

510(k) Number K960916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1996
Decision Date June 04, 1996
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSJ Device Classification - Class 2, Special Controls

Product Code DSJ Alarm, Blood-pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1100
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.