510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K021984Substantially Equivalent

Punctsure Ultrasound Vascular Imaging System; Puncturesure Vascular Imaging Procedure Kit

Inceptio Medical Technologies, LC, Farmington UT / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K021984 is the FDA 510(k) clearance record for PUNCTSURE ULTRASOUND VASCULAR IMAGING SYSTEM; PUNCTURESURE VASCULAR IMAGING PROCEDURE KIT, a class II device, cleared for Inceptio Medical Technologies, LC on under FDA product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). FDA records list one 510(k) clearance for Inceptio Medical Technologies, LC. As of , FDA records show no recalls naming K021984.

Clearance record

Decision date
Received
(14 days to decision)
Product code
IYN System, Imaging, Pulsed Doppler, Ultrasonic
Regulation
21 CFR 892.1550
Device class
Class II
Review panel
Radiology
Applicant
Inceptio Medical Technologies, LC 1401 N. Hwy. 89, Farmington UT
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code IYN

Trailing 12 months
53 clearances under product code IYN in the twelve months to October 2026, May 2026 the highest month at 11.
Show the numbers
Monthly 510(k) clearances under FDA product code IYN, trailing twelve months
MonthClearances
November 20256
December 20256
January 20264
February 20261
March 20266
April 20263
May 202611
June 20263
July 20266
August 20263
September 20263
October 20261