Cleared Traditional

K042445 - SITE-RITE NEEDLE GUIDE KITS AND PROBE C...

K042445 is an FDA 510(k) clearance for SITE-RITE NEEDLE GUIDE KITS AND PROBE C..., manufactured by Bard Access Systems, Inc.. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K042445 · Bard Access Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
40d
Days
Class 2
Risk

K042445 is an FDA 510(k) clearance for the SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Bard Access Systems, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on October 19, 2004 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - 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 Bard Access Systems, Inc. devices

FDA 510(k) Submission Details - K042445

510(k) Number K042445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2004
Decision Date October 19, 2004
Days to Decision 40 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
67d faster than avg
Panel avg: 107d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

ITX Device Classification - Class 2, Special Controls

Product Code ITX Transducer, Ultrasonic, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
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

Citech
ROBERT MOSENKIS

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 - ITX Transducer, Ultrasonic, Diagnostic

All 239
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K042445.
V5MS TRANSDUCER AND MPT7-4 MULTIPLANE TRANSESOPHAGEAL TRANSDUCER
K052021 · Siemens Medical Solutions USA, Inc. · Aug 2005
SURE-POINT MIDLINE STEPPING AND STABILIZATION SYSTEM
K050724 · C.R. Bard, Inc. · Apr 2005
SONICATH ULTRA IMAGING CATHETER 3.2F 20MHZ, MODELS 37410/456221/C1020
K041818 · Boston Scientific Corp · Nov 2004
EG-3630UR
K041395 · Pentax Precision Instrument Corp. · Jun 2004
FG-36UX FIBER ULTRASOUND GASTROSCOPE
K041396 · Pentax Precision Instrument Corp. · Jun 2004
EG-3830UT
K041397 · Pentax Precision Instrument Corp. · Jun 2004