Cleared Traditional

K900797 - STOCKERT SHILEY DUAL PRESSURE CONTROL M...

K900797 is an FDA 510(k) clearance for STOCKERT SHILEY DUAL PRESSURE CONTROL M..., manufactured by Shiley, Inc.. The device is a Class 2 Cardiovascular device with product code DXS cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K900797 · Shiley, Inc. · Cardiovascular device
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May 1990
Decision
79d
Days
Class 2
Risk

K900797 is an FDA 510(k) clearance for the STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR. Classified as Gauge, Pressure, Coronary, Cardiopulmonary Bypass (product code DXS), Class II - Special Controls.

Submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on May 10, 1990 after a review of 79 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shiley, Inc. devices

FDA 510(k) Submission Details - K900797

510(k) Number K900797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1990
Decision Date May 10, 1990
Days to Decision 79 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
46d faster than avg
Panel avg: 125d · This submission: 79d
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 8
Devices cleared under the same product code (DXS) and FDA review panel - the closest regulatory comparables to K900797.
PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS
K113235 · Medtronic, Inc. · Dec 2011
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
PMS-2 PRESSURE MONITOR SEPARATOR
K820912 · Delta Medical Industries · May 1982