Cleared Traditional

K241662 - Ultrasound Transducer Cover (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K241662 · Vitrolife Sweden AB · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2024
Decision
81d
Days
Class 2
Risk

K241662 is an FDA 510(k) clearance for the Ultrasound Transducer Cover. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Vitrolife Sweden AB (Västra Frölunda, SE). The FDA issued a Cleared decision on August 30, 2024 after a review of 81 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 Vitrolife Sweden AB devices

Submission Details

510(k) Number K241662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2024
Decision Date August 30, 2024
Days to Decision 81 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
26d faster than avg
Panel avg: 107d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 408
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K241662.
ULTRASONIC PROBE UM-3R (UM-3R)
K250883 · Olympus Medical Systems Corporation · Sep 2025
ULTRASONIC PROBE UM-S20-17S (UM-S20-17S)
K250762 · Olympus Medical Systems Corporation · Jul 2025
Mendaera Guidance System
K250524 · Mendaera, Inc. · Jul 2025
Accuro® 3S Needle Guide Kit
K250469 · Rivanna Medical, Inc. · Jun 2025
UltraDrape UGPIV Barrier and Securement (34-15)
K233965 · Parker Laboratories, Inc. · Aug 2024
Transducer Probe Cover
K241615 · Hony Medical Co., Ltd. · Jul 2024