Cleared Traditional

ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER (K121243) - FDA 510(k) Clearance

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

K121243 · MEDA Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
373d
Days
Class 2
Risk

K121243 is an FDA 510(k) clearance for the ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by MEDA Co., Ltd. (Potomac, US). The FDA issued a Cleared decision on May 3, 2013 after a review of 373 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 MEDA Co., Ltd. devices

Submission Details

510(k) Number K121243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2012
Decision Date May 03, 2013
Days to Decision 373 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
266d slower than avg
Panel avg: 107d · This submission: 373d
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 214
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K121243.
Site-Rite 6 Ultrasound System with Pinpoint GT Technology
K142443 · C.R. Bard, Inc. · Oct 2014
SC2000 and ACUSON X300 Diagnostic Ultrasound Systems
K142395 · Siemens Medical Solutions USA, Inc. · Sep 2014
M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM
K131690 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jul 2013
ILAB ULTRASOUND IMAGING SYSTEM
K130243 · Boston Scientific Corp · Mar 2013
ILAB ULTRASOUND IMAGING SYSTEM
K123535 · Boston Scientific Corp · Jan 2013
DC-8/DC-8 PRO/DC-8, CV/DC-8, EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM
K123185 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Nov 2012