Cleared Traditional

K842194 - PRESSURE MONITOR

K842194 is an FDA 510(k) clearance for PRESSURE MONITOR, manufactured by Norton Texas Medical Products. The device is a Class 2 Cardiovascular device with product code DXS cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K842194 · Norton Texas Medical Products · Cardiovascular device
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Aug 1984
Decision
84d
Days
Class 2
Risk

K842194 is an FDA 510(k) clearance for the PRESSURE MONITOR. Classified as Gauge, Pressure, Coronary, Cardiopulmonary Bypass (product code DXS), Class II - Special Controls.

Submitted by Norton Texas Medical Products (Mchenry, US). The FDA issued a Cleared decision on August 27, 1984 after a review of 84 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 Norton Texas Medical Products devices

FDA 510(k) Submission Details - K842194

510(k) Number K842194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1984
Decision Date August 27, 1984
Days to Decision 84 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 125d · This submission: 84d
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 11
Devices cleared under the same product code (DXS) and FDA review panel - the closest regulatory comparables to K842194.
PRESSURE BARRIER KIT CAT. NO. PBK-3
K873802 · American Omni Medical, Inc. · Nov 1987
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