Cleared Traditional

K850029 - UTAH PRESSURE TRANSDUCER CALIBRATOR TRU-CAL

K850029 is an FDA 510(k) clearance for UTAH PRESSURE TRANSDUCER CALIBRATOR TRU-CAL, manufactured by Utah Medical Products, Inc.. The device is a Class 1 Anesthesiology device with product code BXX cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K850029 · Utah Medical Products, Inc. · Anesthesiology device
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Apr 1985
Decision
115d
Days
Class 1
Risk

K850029 is an FDA 510(k) clearance for the UTAH PRESSURE TRANSDUCER CALIBRATOR TRU-CAL. Classified as Calibrator, Pressure, Gas (product code BXX), Class I - General Controls.

Submitted by Utah Medical Products, Inc. (Midvale, US). The FDA issued a Cleared decision on April 29, 1985 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2620 - the FDA anesthesiology and respiratory device 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Utah Medical Products, Inc. devices

FDA 510(k) Submission Details - K850029

510(k) Number K850029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1985
Decision Date April 29, 1985
Days to Decision 115 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 140d · This submission: 115d
Pathway characteristics
Predicate-based equivalence.

BXX Device Classification - Class 1, General Controls

Product Code BXX Calibrator, Pressure, Gas
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.2620
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.