Cleared Traditional

VASCULAR TECHNOLOGY UNIOX OXYGEN ALARM (K890058) - FDA 510(k) Clearance

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

K890058 · Vascular Technology Incorporated · Anesthesiology device
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Nov 1989
Decision
319d
Days
Class 2
Risk

K890058 is an FDA 510(k) clearance for the VASCULAR TECHNOLOGY UNIOX OXYGEN ALARM. Classified as Analyzer, Gas, Oxygen, Gaseous-phase (product code CCL), Class II - Special Controls.

Submitted by Vascular Technology Incorporated (Chelmsford, US). The FDA issued a Cleared decision on November 21, 1989 after a review of 319 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1720 - 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. Elevated predicate reliance profile. 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 Vascular Technology Incorporated devices

Submission Details

510(k) Number K890058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1989
Decision Date November 21, 1989
Days to Decision 319 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
179d slower than avg
Panel avg: 140d · This submission: 319d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CCL Analyzer, Gas, Oxygen, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1720
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - CCL Analyzer, Gas, Oxygen, Gaseous-phase

All 18
Devices cleared under the same product code (CCL) and FDA review panel - the closest regulatory comparables to K890058.
HP ANESTHESIA GAS MONITOR (WATERTRAP), MODEL A02
K982619 · Hewlett-Packard Co. · Aug 1998
COMPANION RETROFIT OXYGEN CONCENTRATION INDICATOR
K920338 · Puritan Bennett Corp. · Aug 1992
AG-820PA FI02 MODULE
K896359 · Nihon Kohden America, Inc. · Mar 1990
MULTINEX MONITOR (MODIFICATION)
K883254 · Datascope Corp. · Sep 1988
OHMEDA 5250 RGM (RESPIRATORY GAS MONITOR)
K882743 · Ohmeda Medical · Aug 1988
OHMEDA 5120 OXYGEN MONITOR
K853082 · Ohmeda Medical · Jul 1985