Cleared Traditional

K843969 - MODEL P23XL PHYSIOLOGICAL PRESSURE TRANSDUCER

K843969 is an FDA 510(k) clearance for MODEL P23XL PHYSIOLOGICAL PRESSURE TRAN..., manufactured by Gould, Inc.. The device is a Class 2 Cardiovascular device with product code DXO cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K843969 · Gould, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1985
Decision
104d
Days
Class 2
Risk

K843969 is an FDA 510(k) clearance for the MODEL P23XL PHYSIOLOGICAL PRESSURE TRANSDUCER. Classified as Transducer, Pressure, Catheter Tip (product code DXO), Class II - Special Controls.

Submitted by Gould, Inc. (Oxnard, US). The FDA issued a Cleared decision on January 23, 1985 after a review of 104 days - within the typical 510(k) review window.

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 Gould, Inc. devices

FDA 510(k) Submission Details - K843969

510(k) Number K843969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1984
Decision Date January 23, 1985
Days to Decision 104 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
21d faster than avg
Panel avg: 125d · This submission: 104d
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 52
Devices cleared under the same product code (DXO) and FDA review panel - the closest regulatory comparables to K843969.
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
TRANSDUCER-MONITOR INTERFACING
K842150 · Millar Instruments, Inc. · Oct 1984
VSM R1
K842213 · Physio-Control Corp. · Oct 1984
MODEL 110-5 & 140-8
K842005 · Camino Laboratories, Inc. · Aug 1984