Cleared Traditional

K864090 - SHELF LIFE CHANGE OF STERILE DEVICES

K864090 is an FDA 510(k) clearance for SHELF LIFE CHANGE OF STERILE DEVICES, 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 178-day FDA review.

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

FDA 510(k) Submission Details - K864090

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
Combination Product No
PCCP Authorized No
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.

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 K864090.
MODEL 700 PATIENT MONITOR
K882118 · Ivy Biomedical Systems, Inc. · Aug 1988
TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30
K872596 · American Edwards Laboratories · Sep 1987
MX900-DPT, DISPOSABLE PRESSURE TRANSDUCER
K870301 · Medex, Inc. · May 1987
GOULD XCALIBER
K862344 · Bio-Tek Instruments, Inc. · Aug 1986
DISPOSABLE FLUSH DEVICE
K860681 · Hewlett-Packard Co. · Jun 1986
MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATOR
K855145 · Gould, Inc. · Feb 1986