Cleared Traditional

K880830 - SENTORR ARTERIAL PRESSURE SENSOR

K880830 is the FDA 510(k) clearance for SENTORR ARTERIAL PRESSURE SENSOR by Ohmeda Medical. It is a Class 2 Cardiovascular device (product code DXO) cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K880830 · Ohmeda Medical · Cardiovascular device
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Aug 1988
Decision
164d
Days
Class 2
Risk

K880830 is an FDA 510(k) clearance for the SENTORR ARTERIAL PRESSURE SENSOR. Classified as Transducer, Pressure, Catheter Tip (product code DXO), Class II - Special Controls.

Submitted by Ohmeda Medical (Tampa, US). The FDA issued a Cleared decision on August 12, 1988 after a review of 164 days - an extended review cycle.

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 Ohmeda Medical devices

Submission Details

510(k) Number K880830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1988
Decision Date August 12, 1988
Days to Decision 164 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
39d slower than avg
Panel avg: 125d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 24
Devices cleared under the same product code (DXO) and FDA review panel - the closest regulatory comparables to K880830.
PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600
K925638 · Baxter Healthcare Corp · Oct 1993
SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER
K910429 · Baxter Healthcare Corp · Jul 1991
ULTRASONIC IMAGING CATHETER
K883202 · Boston Scientific Corp · Nov 1988
VITALERT 2000 VITAL SIGNS MONITOR
K882031 · Draeger Medical, Inc. · Jul 1988
VSM R1
K842213 · Physio-Control Corp. · Oct 1984
BP TRANSDUCER HOLDERS TH-2,3 & 4
K832384 · American Bentley · Nov 1983