Cleared Traditional

K896435 - HP SONOS 500 AND SONOS 1000 ULTRA. IMAG...

K896435 is the FDA 510(k) clearance for HP SONOS 500 AND SONOS 1000 ULTRA. IMAG... by Hewlett-Packard Co.. It is a Class 2 Cardiovascular device (product code DPT) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K896435 · Hewlett-Packard Co. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1990
Decision
90d
Days
Class 2
Risk

K896435 is an FDA 510(k) clearance for the HP SONOS 500 AND SONOS 1000 ULTRA. IMAGING SYSTEM. Classified as Probe, Blood-flow, Extravascular (product code DPT), Class II - Special Controls.

Submitted by Hewlett-Packard Co. (Andover, US). The FDA issued a Cleared decision on February 7, 1990 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 Hewlett-Packard Co. devices

Submission Details

510(k) Number K896435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1989
Decision Date February 07, 1990
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K896435.
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
APX CARDIO ECHOCARDIOGRAPHY SYSTEM #H4300
K873214 · General Electric Co. · Jun 1988
ACCUCOM 2
K874138 · Datascope Corp. · Jun 1988
SSH-160A ULTRASONIC PULSED ECHO IMAGING SYSTEM
K875266 · Toshiba Medical Systems · Apr 1988