Cleared Traditional

K896437 - KONTRON SIGMA 44 HVCD ULTRASOUND IMAGIN...

K896437 is an FDA 510(k) clearance for KONTRON SIGMA 44 HVCD ULTRASOUND IMAGIN..., manufactured by Kontron Instruments, Inc.. The device is a Class 2 Cardiovascular device with product code DPT cleared through the Traditional 510(k) pathway after a 389-day FDA review.

K896437 · Kontron Instruments, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1990
Decision
389d
Days
Class 2
Risk

K896437 is an FDA 510(k) clearance for the KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM. Classified as Probe, Blood-flow, Extravascular (product code DPT), Class II - Special Controls.

Submitted by Kontron Instruments, Inc. (Everett, US). The FDA issued a Cleared decision on December 3, 1990 after a review of 389 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Kontron Instruments, Inc. devices

FDA 510(k) Submission Details - K896437

510(k) Number K896437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1989
Decision Date December 03, 1990
Days to Decision 389 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
264d slower than avg
Panel avg: 125d · This submission: 389d
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 13
Devices cleared under the same product code (DPT) and FDA review panel - the closest regulatory comparables to K896437.
TRANSTAR PRESSURE TRANSDUCER
K942377 · Medex, Inc. · Aug 1994
TRANSESOPHAGEAL TRANSDUCER THERMAL SAFETY
K912404 · Hewlett-Packard Co. · Nov 1991
SONOS 500 AND SONOS 1000 ULTRASOUND IMAGING SYSTEM
K905728 · Hewlett-Packard Co. · Mar 1991
HP SONOS 500 AND SONOS 1000 ULTRA. IMAGING SYSTEM
K896435 · Hewlett-Packard Co. · Feb 1990
APX CARDIO ECHOCARDIOGRAPHY SYSTEM #H4300
K873214 · General Electric Co. · Jun 1988
ACCUCOM 2
K874138 · Datascope Corp. · Jun 1988