Cleared Traditional

K860526 - NOVA BALLOON THERMODILUTION PRESSURE TRANS CATH

K860526 is an FDA 510(k) clearance for NOVA BALLOON THERMODILUTION PRESSURE TR..., manufactured by Nova Medical Specialties. The device is a Class 2 Cardiovascular device with product code DXO cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K860526 · Nova Medical Specialties · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1986
Decision
80d
Days
Class 2
Risk

K860526 is an FDA 510(k) clearance for the NOVA BALLOON THERMODILUTION PRESSURE TRANS CATH. Classified as Transducer, Pressure, Catheter Tip (product code DXO), Class II - Special Controls.

Submitted by Nova Medical Specialties (Indian Mills, US). The FDA issued a Cleared decision on May 2, 1986 after a review of 80 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nova Medical Specialties devices

FDA 510(k) Submission Details - K860526

510(k) Number K860526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1986
Decision Date May 02, 1986
Days to Decision 80 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 125d · This submission: 80d
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 58
Devices cleared under the same product code (DXO) and FDA review panel - the closest regulatory comparables to K860526.
DISPOSABLE CATHETER PRESSURE TRANSDUCER
K874165 · Deseret Medical, Inc. · Jun 1988
ESCORT PORTABLE PATIENT MONITOR
K872291 · Medical Data Electronics · Sep 1987
CAMINO COMPARTMENTAL PRESS MONITOR CATH/110-4D
K863969 · Camino Laboratories, Inc. · May 1987
MODEL P23XL PHYSIOLOGICAL PRESSURE TRANSDUCER
K843969 · Gould, Inc. · Jan 1985
TRANSDUCER-MONITOR INTERFACING
K842150 · Millar Instruments, Inc. · Oct 1984
VSM R1
K842213 · Physio-Control Corp. · Oct 1984