Cleared Traditional

K942377 - TRANSTAR PRESSURE TRANSDUCER

K942377 is an FDA 510(k) clearance for TRANSTAR PRESSURE TRANSDUCER, manufactured by Medex, Inc.. The device is a Class 2 Cardiovascular device with product code DPT cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K942377 · Medex, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1994
Decision
90d
Days
Class 2
Risk

K942377 is an FDA 510(k) clearance for the TRANSTAR PRESSURE TRANSDUCER. Classified as Probe, Blood-flow, Extravascular (product code DPT), Class II - Special Controls.

Submitted by Medex, Inc. (Hilliard, US). The FDA issued a Cleared decision on August 16, 1994 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2120 - 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 Medex, Inc. devices

FDA 510(k) Submission Details - K942377

510(k) Number K942377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1994
Decision Date August 16, 1994
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPT Device Classification - Class 2, Special Controls

Product Code DPT Probe, Blood-flow, Extravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2120
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 - DPT Probe, Blood-flow, Extravascular

All 32
Devices cleared under the same product code (DPT) and FDA review panel - the closest regulatory comparables to K942377.
VENTRICULAR CATHETER BLOOD FLOW MONITORING PROBE KIT AND VENTRAFLO BLOOD FLOW MONITORING PROBE KIT
K962700 · Vasamedics, LLC · Apr 1997
TRIMFLO PARENCHYMAL BLOOD FLOW MONITORING PROBE KIT
K961368 · Vasamedics, LLC · Oct 1996
LASERFLO BLOOD PERFUSION SINGLE USE PROBES MODELS SUP-440, SUPR-434 SUP-433
K951832 · Vasamedics, LLC · Mar 1996
TRANSESOPHAGEAL TRANSDUCER THERMAL SAFETY
K912404 · Hewlett-Packard Co. · Nov 1991
SONOS 500 AND SONOS 1000 ULTRASOUND IMAGING SYSTEM
K905728 · Hewlett-Packard Co. · Mar 1991
KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM
K896437 · Kontron Instruments, Inc. · Dec 1990