Cleared Traditional

K884235 - COMBITRANS DISPOSABLE PRESSURE TRANSDUCER KIT

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

K884235 · Burron Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K884235

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.

DRS Device Classification - Class 2, Special Controls

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 105
Devices cleared under the same product code (DRS) and FDA review panel - the closest regulatory comparables to K884235.
SERIES 51 AND 53 DISPOSABLE PRESSURE TRANSDUCERS
K904777 · Baxter Healthcare Corp · Jan 1991
ADVANCE DISPOSABLE PRESSURE TRANSDUCER
K904601 · Advance Medical Designs, Inc. · Dec 1990
MORSE DT MANIFOLD
K902472 · North American Instrument Corp. · Aug 1990
MINIFLOW DISPOSABLE PRESSURE TRANSDUCER 63-600F
K885296 · Baxter Healthcare Corp · Jan 1989
BARO-GRAF 24
K881297 · Instromedix, Inc. · Sep 1988
MX860, REUSABLE PRESSURE TRANSDUCER
K883095 · Medex, Inc. · Sep 1988