Cleared Abbreviated

K021984 - PUNCTSURE ULTRASOUND VASCULAR IMAGING SYSTEM

Also marketed or referenced as:
PUNCTURESURE VASCULAR IMAGING PROCEDURE KIT

K021984 is an FDA 510(k) clearance for PUNCTSURE ULTRASOUND VASCULAR IMAGING S..., manufactured by Inceptio Medical Technologies, LC. The device is a Class 2 Radiology device with product code IYN cleared through the Abbreviated 510(k) pathway after a 14-day FDA review.

K021984 · Inceptio Medical Technologies, LC · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
14d
Days
Class 2
Risk

K021984 is an FDA 510(k) clearance for the PUNCTSURE ULTRASOUND VASCULAR IMAGING 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 Inceptio Medical Technologies, LC (Farmington, US). The FDA issued a Cleared decision on July 2, 2002 after a review of 14 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Inceptio Medical Technologies, LC devices

FDA 510(k) Submission Details - K021984

510(k) Number K021984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2002
Decision Date July 02, 2002
Days to Decision 14 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 107d · This submission: 14d
Pathway characteristics
Standards-based clearance path. 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 Peers - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 1052
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K021984.
SSA-700A, APLIO DIAGNOSTIC ULTRASOUND SYSTEM
K022400 · Toshiba America Medical Systems, In.C · Aug 2002
PHILIPS M2424 DIAGNOSTIC ULTRASOUND SYSTEM &PHILIPS 21315 DIAGNOSTIC ULTRASOUND TRANSDUCER
K022303 · Philips Ultrasound, Inc. · Jul 2002
CYPRESS ULTRASOUND SYSTEM
K021497 · Acuson Corp. · Jul 2002
SONOSITE HAND-CARIED UNTRASOUND SYSTEM (POWERSERIES)
K021628 · Sonosite,Inc. · May 2002
AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING MODE AND MUSCULOSKELETAL INDICATION)
K014168 · Biosound Esaote, Inc. · Apr 2002
GE VIVID 3 EXPERT
K020789 · General Electric Co. · Apr 2002