Cleared Traditional

K880830 - SENTORR ARTERIAL PRESSURE SENSOR

K880830 is an FDA 510(k) clearance for SENTORR ARTERIAL PRESSURE SENSOR, manufactured by Ohmeda Medical. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K880830

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.

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 57
Devices cleared under the same product code (DXO) and FDA review panel - the closest regulatory comparables to K880830.
PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER
K894286 · Ppg Industries, Inc. · Oct 1989
ULTRASONIC IMAGING CATHETER
K883202 · Boston Scientific Corp · Nov 1988
PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER
K883436 · Ppg Industries, Inc. · Oct 1988
VITALERT 2000 VITAL SIGNS MONITOR
K882031 · Draeger Medical, Inc. · Jul 1988
DISPOSABLE CATHETER PRESSURE TRANSDUCER
K874165 · Deseret Medical, Inc. · Jun 1988
ESCORT PORTABLE PATIENT MONITOR
K872291 · Medical Data Electronics · Sep 1987