Cleared Traditional

K842352 - PRESSURE MONITORING KIT

K842352 is an FDA 510(k) clearance for PRESSURE MONITORING KIT, manufactured by Utah Medical Products, Inc.. The device is a Class 2 Cardiovascular device with product code DRS cleared through the Traditional 510(k) pathway after a 283-day FDA review.

K842352 · Utah Medical Products, Inc. · Cardiovascular device
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Mar 1985
Decision
283d
Days
Class 2
Risk

K842352 is an FDA 510(k) clearance for the PRESSURE MONITORING KIT. Classified as Transducer, Blood-pressure, Extravascular (product code DRS), Class II - Special Controls.

Submitted by Utah Medical Products, Inc. (Lehi, US). The FDA issued a Cleared decision on March 25, 1985 after a review of 283 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2850 - 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 Utah Medical Products, Inc. devices

FDA 510(k) Submission Details - K842352

510(k) Number K842352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1984
Decision Date March 25, 1985
Days to Decision 283 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
158d slower than avg
Panel avg: 125d · This submission: 283d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRS Device Classification - Class 2, Special Controls

Product Code DRS Transducer, Blood-pressure, Extravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2850
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 - DRS Transducer, Blood-pressure, Extravascular

All 87
Devices cleared under the same product code (DRS) and FDA review panel - the closest regulatory comparables to K842352.
DISPOS. PRESSURE KIT 1295K SERIES
K843273 · Hewlett-Packard Co. · Jun 1985
MEDI-TRACE TRANSDUC PHYS PRESSURE MONITO
K843580 · Graphic Controls Corp. · May 1985
UTAH DISPOSABLE PRESSURE TRANSDUCER
K841788 · Utah Medical Products, Inc. · Mar 1985
PRESSURE TRANSDUCER DOME 1295C
K841613 · Hewlett-Packard Co. · Oct 1984
DESERET DISPOSABLE PRESSURE TRANSDUCER
K841968 · Parke-Davis Co. · Aug 1984
TRANTEC PHYSIOLOGICAL PRESSURE TRANSDUC
K840023 · American Bentley · Jun 1984