Cleared Traditional

K202119 - AcuSee AS-P1000 System

K202119 is the FDA 510(k) clearance for AcuSee AS-P1000 System by Weipeng (Suzhou) Medical Devices Co., Ltd.. It is a Class 2 Radiology device (product code IYO) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K202119 · Weipeng (Suzhou) Medical Devices Co., Ltd. · Radiology device
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Oct 2020
Decision
69d
Days
Class 2
Risk

K202119 is an FDA 510(k) clearance for the AcuSee AS-P1000 System. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Weipeng (Suzhou) Medical Devices Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on October 7, 2020 after a review of 69 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 Weipeng (Suzhou) Medical Devices Co., Ltd. devices

Submission Details

510(k) Number K202119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2020
Decision Date October 07, 2020
Days to Decision 69 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
38d faster than avg
Panel avg: 107d · This submission: 69d
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 Consultant

Springborne Life Sciences
Geetha Rao

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

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