Cleared Traditional

K912172 - SAFEWEDGE(TM) RELIEF VALVE DEVICE

K912172 is an FDA 510(k) clearance for SAFEWEDGE(TM) RELIEF VALVE DEVICE, manufactured by Sunscope Intl., Inc.. The device is a Class 2 Cardiovascular device with product code KRB cleared through the Traditional 510(k) pathway after a 134-day FDA review.

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.

FDA 510(k) Submission Details - K912172

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.

KRB Device Classification - Class 2, Special Controls

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 31
Devices cleared under the same product code (KRB) and FDA review panel - the closest regulatory comparables to K912172.
PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR
K991886 · Pulsion Medical Systems, Inc. · May 2000
CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT
K936182 · Ohmeda Medical · Mar 1994
PACEVIEW
K915627 · Micromedical Industries, Ltd. · Mar 1992
INTERFLO MEDICAL MODEL OXI/CO FILA. THERMO. CATH.
K902627 · Biometric Research Institute, Inc. · Feb 1991
INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER
K900710 · Intec Medical, Inc. · Oct 1990
PACEMATE FLOW DIRECTED THERMAL DILUTION CATHETER
K900317 · Elecath · Jun 1990
K912172 · SAFEWEDGE(TM) RELIEF VALVE DEVICE
Download PDF Sunscope Intl., Inc.