Cleared Traditional

K912045 - TMP PRESSURE ISOLATORR

K912045 is an FDA 510(k) clearance for TMP PRESSURE ISOLATORR, manufactured by Lifestream Int'L, Inc.. The device is a Class 2 Cardiovascular device with product code DXS cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K912045 · Lifestream Int'L, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1991
Decision
176d
Days
Class 2
Risk

K912045 is an FDA 510(k) clearance for the TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST. Classified as Gauge, Pressure, Coronary, Cardiopulmonary Bypass (product code DXS), Class II - Special Controls.

Submitted by Lifestream Int'L, Inc. (The Woodlands, US). The FDA issued a Cleared decision on October 31, 1991 after a review of 176 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4310 - 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 Lifestream Int'L, Inc. devices

FDA 510(k) Submission Details - K912045

510(k) Number K912045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1991
Decision Date October 31, 1991
Days to Decision 176 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 125d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXS Device Classification - Class 2, Special Controls

Product Code DXS Gauge, Pressure, Coronary, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4310
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 - DXS Gauge, Pressure, Coronary, Cardiopulmonary Bypass

All 9
Devices cleared under the same product code (DXS) and FDA review panel - the closest regulatory comparables to K912045.
PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS
K113235 · Medtronic, Inc. · Dec 2011
STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR
K900797 · Shiley, Inc. · May 1990
STOCKERT-SHILEY CAPS AND CAPS DUAL PRESSURE MODULE
K862836 · Shiley, Inc. · Sep 1986
PRESSURE DISPLAY BOX #60000/TUBING SET #61000
K852232 · Dlp, Inc. · Aug 1985
PM-3
K831750 · Delta Medical Industries · Jul 1983
GAMBRO PRESSURE MONITOR PRM 10
K822822 · Gambro, Inc. · Oct 1982