Cleared Traditional

K014116 - HAND-CARRIED ULTRASOUND SYSTEM

K014116 is an FDA 510(k) clearance for HAND-CARRIED ULTRASOUND SYSTEM, manufactured by Sonosite,Inc.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 6-day FDA review.

K014116 · Sonosite,Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
6d
Days
Class 2
Risk

K014116 is an FDA 510(k) clearance for the HAND-CARRIED 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 Sonosite,Inc. (Bothell, US). The FDA issued a Cleared decision on December 20, 2001 after a review of 6 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 Sonosite,Inc. devices

FDA 510(k) Submission Details - K014116

510(k) Number K014116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2001
Decision Date December 20, 2001
Days to Decision 6 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 107d · This submission: 6d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

IYN Device Classification - Class 2, Special Controls

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 Consultant

Tuv Product Service, Inc.
MARK JOB

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 - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 873
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K014116.
LOGIQ 3
K020263 · General Electric Co. · Feb 2002
GE LOGIQ 5
K014097 · GE Medical Systems · Jan 2002
M2540 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL M2540
K014191 · Philips Medical Systems · Jan 2002
SSD-5000 DIAGNOSTIC ULTRASOUND SYSTEM
K012080 · Aloka Co., Ltd. · Aug 2001
ALOKA SSD-5500 WITH KI AND A-SMA
K011457 · Aloka Co., Ltd. · May 2001
GE LOGIQ 9, MODEL 2188900-X
K011188 · GE Medical Systems · May 2001