Cleared Traditional

K884235 - COMBITRANS DISPOSABLE PRESSURE TRANSDUC...

K884235 is the FDA 510(k) clearance for COMBITRANS DISPOSABLE PRESSURE TRANSDUC... by Burron Medical, Inc.. It is a Class 2 Cardiovascular device (product code DRS) cleared through the Traditional 510(k) pathway after a 515-day FDA review.

K884235 · Burron Medical, Inc. · Cardiovascular device
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Mar 1990
Decision
515d
Days
Class 2
Risk

K884235 is an FDA 510(k) clearance for the COMBITRANS DISPOSABLE PRESSURE TRANSDUCER KIT. Classified as Transducer, Blood-pressure, Extravascular (product code DRS), Class II - Special Controls.

Submitted by Burron Medical, Inc. (Bethlehem, US). The FDA issued a Cleared decision on March 6, 1990 after a review of 515 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2850 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Burron Medical, Inc. devices

Submission Details

510(k) Number K884235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1988
Decision Date March 06, 1990
Days to Decision 515 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
390d slower than avg
Panel avg: 125d · This submission: 515d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRS Transducer, Blood-pressure, Extravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2850
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 - DRS Transducer, Blood-pressure, Extravascular

All 32
Devices cleared under the same product code (DRS) and FDA review panel - the closest regulatory comparables to K884235.
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K860681 · Hewlett-Packard Co. · Jun 1986