Cleared Traditional

K233965 - UltraDrape UGPIV Barrier and Securement (34-15)

K233965 is an FDA 510(k) clearance for UltraDrape UGPIV Barrier and Securement..., manufactured by Parker Laboratories, Inc.. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K233965 · Parker Laboratories, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2024
Decision
244d
Days
Class 2
Risk

K233965 is an FDA 510(k) clearance for the UltraDrape UGPIV Barrier and Securement (34-15). Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Parker Laboratories, Inc. (Fairfield, US). The FDA issued a Cleared decision on August 15, 2024 after a review of 244 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Parker Laboratories, Inc. devices

FDA 510(k) Submission Details - K233965

510(k) Number K233965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2023
Decision Date August 15, 2024
Days to Decision 244 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 107d · This submission: 244d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - ITX Transducer, Ultrasonic, Diagnostic

All 323
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K233965.
Mendaera Guidance System
K250524 · Mendaera, Inc. · Jul 2025
Accuro® 3S Needle Guide Kit
K250469 · Rivanna Medical, Inc. · Jun 2025
Ultrasound Transducer Cover
K241662 · Vitrolife Sweden AB · Aug 2024
Transducer Probe Cover
K241615 · Hony Medical Co., Ltd. · Jul 2024
TP Pivot Pro™ Needle Guide
K233109 · Civco Medical Solutions · Dec 2023
Endoscopic Ultrasonic Probe (P2612S-L)
K231666 · Fujifilm Healthcare Americas Corporation · Dec 2023