Cleared Traditional

CANON IOL ESTIMATOR KU-1 (K881889) - FDA 510(k) Clearance

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

K881889 · Canon USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1988
Decision
133d
Days
Class 2
Risk

K881889 is an FDA 510(k) clearance for the CANON IOL ESTIMATOR KU-1. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Canon USA, Inc. (Jericho, US). The FDA issued a Cleared decision on September 15, 1988 after a review of 133 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Canon USA, Inc. devices

Submission Details

510(k) Number K881889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1988
Decision Date September 15, 1988
Days to Decision 133 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 107d · This submission: 133d
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 181
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K881889.
RT6800 ECHOCARDIOGRAPHY SYSTEM
K885228 · General Electric Co. · Mar 1989
HP 21362B TRANSESOPHAGEAL ULTRASOUND IMAGING TRANS
K884395 · Hewlett-Packard Co. · Jan 1989
HP 77025A/77030A ULTRA. SYSTEM/HP 77020CV UPGRADE
K883481 · Hewlett-Packard Co. · Nov 1988
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