Cleared Traditional

K221599 - HS40 Diagnostic Ultrasound System

K221599 is the FDA 510(k) clearance for HS40 Diagnostic Ultrasound System by Samsung Medison Co., Ltd.. It is a Class 2 Radiology device (product code IYN) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K221599 · Samsung Medison Co., Ltd. · Radiology device
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Aug 2022
Decision
81d
Days
Class 2
Risk

K221599 is an FDA 510(k) clearance for the HS40 Diagnostic Ultrasound System. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by Samsung Medison Co., Ltd. (Hongcheon-Gun, KR). The FDA issued a Cleared decision on August 22, 2022 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - 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 Samsung Medison Co., Ltd. devices

Submission Details

510(k) Number K221599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2022
Decision Date August 22, 2022
Days to Decision 81 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
26d faster than avg
Panel avg: 107d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
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 - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 779
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K221599.
P12 Elite Series Digital Color Doppler Ultrasound System
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P20 Elite Series Digital Color Doppler Ultrasound System
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K221568 · Kolo Medical (Suzhou) Co., Ltd. · Sep 2022
ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound System
K221190 · Siemens Medical Solutions USA, Inc. · Aug 2022
Vivid E80, Vivid E90, Vivid E95
K220882 · Ge Medical Systems Ultrasound And · Jul 2022
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K221147 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jul 2022