Cleared Traditional

K864000 - FST DISPOSABLE FIBER OPTIC TRANSDUCER #...

K864000 is an FDA 510(k) clearance for FST DISPOSABLE FIBER OPTIC TRANSDUCER #..., manufactured by Fiberoptic Sensor Technlogies, Inc.. The device is a Class 2 Cardiovascular device with product code DXO cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K864000 · Fiberoptic Sensor Technlogies, Inc. · Cardiovascular device
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Jan 1987
Decision
94d
Days
Class 2
Risk

K864000 is an FDA 510(k) clearance for the FST DISPOSABLE FIBER OPTIC TRANSDUCER #0100-00. Classified as Transducer, Pressure, Catheter Tip (product code DXO), Class II - Special Controls.

Submitted by Fiberoptic Sensor Technlogies, Inc. (Plymouth, US). The FDA issued a Cleared decision on January 16, 1987 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2870 - 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 Fiberoptic Sensor Technlogies, Inc. devices

FDA 510(k) Submission Details - K864000

510(k) Number K864000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1986
Decision Date January 16, 1987
Days to Decision 94 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 125d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXO Device Classification - Class 2, Special Controls

Product Code DXO Transducer, Pressure, Catheter Tip
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2870
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 - DXO Transducer, Pressure, Catheter Tip

All 27
Devices cleared under the same product code (DXO) and FDA review panel - the closest regulatory comparables to K864000.
SENTORR ARTERIAL PRESSURE SENSOR
K880830 · Ohmeda Medical · Aug 1988
VITALERT 2000 VITAL SIGNS MONITOR
K882031 · Draeger Medical, Inc. · Jul 1988
ESCORT PORTABLE PATIENT MONITOR
K872291 · Medical Data Electronics · Sep 1987
MODEL P23XL PHYSIOLOGICAL PRESSURE TRANSDUCER
K843969 · Gould, Inc. · Jan 1985
VSM R1
K842213 · Physio-Control Corp. · Oct 1984
BP TRANSDUCER HOLDERS TH-2,3 & 4
K832384 · American Bentley · Nov 1983