Cleared Traditional

K881889 - CANON IOL ESTIMATOR KU-1

K881889 is an FDA 510(k) clearance for CANON IOL ESTIMATOR KU-1, manufactured by Canon USA, Inc.. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K881889 · Canon USA, Inc. · Radiology device
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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

FDA 510(k) Submission Details - K881889

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
Combination Product No
PCCP Authorized No
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.

IYO Device Classification - Class 2, Special Controls

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 659
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K881889.
100-01778-52 ULTRASOUND SYSTEM
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PROBE, IMAGING, ULTRASONIC, MECHANICAL SECTOR
K883965 · Teknar, Inc. · Oct 1988
TEKNAR PERCU-SCAN
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MODEL SSD-870 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
K881834 · Ge Medical Systems Information Technologies · Aug 1988
GENESIS II TRANSCRANIAL PROBE
K883238 · Biosound, Inc. · Aug 1988