Cleared Traditional

HP 77025A/77030A ULTRA. SYSTEM/HP 77020CV UPGRADE (K883481) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K883481 · Hewlett-Packard Co. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1988
Decision
80d
Days
Class 2
Risk

K883481 is an FDA 510(k) clearance for the HP 77025A/77030A ULTRA. SYSTEM/HP 77020CV UPGRADE. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Hewlett-Packard Co. (Andover, US). The FDA issued a Cleared decision on November 4, 1988 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - the FDA radiology and imaging software 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hewlett-Packard Co. devices

Submission Details

510(k) Number K883481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1988
Decision Date November 04, 1988
Days to Decision 80 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 107d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 Radiology devices follow this clearance model.

Regulatory Peers - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 191
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K883481.
ULTRASONIC IMAGING CATHETER FOR CARDIAC APPLI.
K890772 · Boston Scientific Corp · May 1989
RT6800 ECHOCARDIOGRAPHY SYSTEM
K885228 · General Electric Co. · Mar 1989
HP 21362B TRANSESOPHAGEAL ULTRASOUND IMAGING TRANS
K884395 · Hewlett-Packard Co. · Jan 1989
ARTIS 3200 DIAGNOSTIC ULTRASOUND DEVICE
K875251 · Philips Medical Systems (Cleveland), Inc. · May 1988
VOLUMETRIC PACKAGE STEPPER H4222AA/CALCU. H4222AB
K872307 · General Electric Co. · Sep 1987
7.5 MHZ LINEAR SMALL PARTS PROBE
K863338 · Siemens Medical Solutions USA, Inc. · Nov 1986