Cleared Traditional

SAFEWEDGE(TM) RELIEF VALVE DEVICE (K912172) - FDA 510(k) Clearance

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

K912172 · Sunscope Intl., Inc. · Cardiovascular device
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Sep 1991
Decision
134d
Days
Class 2
Risk

K912172 is an FDA 510(k) clearance for the SAFEWEDGE(TM) RELIEF VALVE DEVICE. Classified as Probe, Thermodilution (product code KRB), Class II - Special Controls.

Submitted by Sunscope Intl., Inc. (Westlake Village, US). The FDA issued a Cleared decision on September 27, 1991 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1915 - 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 Sunscope Intl., Inc. devices

Submission Details

510(k) Number K912172 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1991
Decision Date September 27, 1991
Days to Decision 134 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 125d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRB Probe, Thermodilution
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1915
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 - KRB Probe, Thermodilution

All 36
Devices cleared under the same product code (KRB) and FDA review panel - the closest regulatory comparables to K912172.
PiCCO Catheter
K171620 · Pulsion Medical Systems SE · Feb 2018
THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM
K884318 · Abbott Laboratories · Dec 1988
USCI SAFE-T-CLOTH THERMODILUTION CAT.
K791873 · C.R. Bard, Inc. · Nov 1979
CATHETER, THERMAL DILUTION, ANIMAL & PED
K760064 · Instrumentation Laboratory CO · Jul 1976
CATHETER, THERMAL DILUTION, PEDIATRIC
K760065 · Instrumentation Laboratory CO · Jul 1976
CATHETER, THERMAL DILUTION, OPEN CHEST
K760067 · Instrumentation Laboratory CO · Jul 1976