510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K042445Substantially Equivalent

Site-Rite Needle Guide Kits and Probe Cover Kit

Bard Access Systems, Inc., Salt Lake City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K042445 is the FDA 510(k) clearance record for SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT, a class II device, cleared for Bard Access Systems, Inc. on under FDA product code ITX (Transducer, Ultrasonic, Diagnostic). FDA records list 31 510(k) clearances for Bard Access Systems, Inc., from to . As of , FDA records show no recalls naming K042445.

Clearance record

Decision date
Received
(40 days to decision)
Product code
ITX Transducer, Ultrasonic, Diagnostic
Regulation
21 CFR 892.1570
Device class
Class II
Review panel
Radiology
Applicant
Bard Access Systems, Inc. 5425 W. Amelia Earhart Dr., Salt Lake City UT
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code ITX

Trailing 12 months
6 clearances under product code ITX in the twelve months to October 2026, July 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code ITX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20263
August 20262
September 20261
October 20260