Cleared Traditional

SHELF LIFE CHANGE OF STERILE DEVICES (K864090) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K864090 · Utah Medical Products, Inc. · Cardiovascular device
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Mar 1987
Decision
178d
Days
Class 2
Risk

K864090 is an FDA 510(k) clearance for the SHELF LIFE CHANGE OF STERILE DEVICES. Classified as Transducer, Blood-pressure, Extravascular (product code DRS), Class II - Special Controls.

Submitted by Utah Medical Products, Inc. (Midvale, US). The FDA issued a Cleared decision on March 20, 1987 after a review of 178 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

Submission Details

510(k) Number K864090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1986
Decision Date March 20, 1987
Days to Decision 178 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 125d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 18
Devices cleared under the same product code (DRS) and FDA review panel - the closest regulatory comparables to K864090.
MERITRANS(TM) DISPOSABLE TRANSDUCER
K920977 · Merit Medical Systems, Inc. · Dec 1992
SERIES 51 AND 53 DISPOSABLE PRESSURE TRANSDUCERS
K904777 · Baxter Healthcare Corp · Jan 1991
MINIFLOW DISPOSABLE PRESSURE TRANSDUCER 63-600F
K885296 · Baxter Healthcare Corp · Jan 1989
DISPOSABLE FLUSH DEVICE
K860681 · Hewlett-Packard Co. · Jun 1986
DISPOS. PRESSURE KIT 1295K SERIES
K843273 · Hewlett-Packard Co. · Jun 1985
PRESSURE TRANSDUCER DOME 1295C
K841613 · Hewlett-Packard Co. · Oct 1984