Cleared Traditional

Bladder Scanner, Model Name:M5 (K213488) - FDA 510(k) Clearance

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

K213488 · Suzhou Peaksonic Medical Technology Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2022
Decision
242d
Days
Class 2
Risk

K213488 is an FDA 510(k) clearance for the Bladder Scanner, Model Name:M5. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Suzhou Peaksonic Medical Technology Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on July 1, 2022 after a review of 242 days - an extended review 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: 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 Suzhou Peaksonic Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K213488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2021
Decision Date July 01, 2022
Days to Decision 242 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
135d slower than avg
Panel avg: 107d · This submission: 242d
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 215
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K213488.
FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)
K223902 · Echosens · Mar 2023
Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P
K222787 · Chongqing Sunkingdom Medical Instrument Co., Ltd. · Jan 2023
QT Scanner 2000 Model A
K220933 · Qt Imaging, Inc. · Aug 2022
NAVIRFA Scope
K211529 · Navifus Corporation · May 2022
ATUSA™ Automated 3D Breast Ultrasound System
K213620 · Isono Health, Inc. · Apr 2022
EchoSK and EchoSGyn modules for EchoS Family devices
K212851 · Echolight S.P.A · Mar 2022