# K123424: MDU5 Plus Sterile Bag

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Feb 20, 2013 after 105 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K844472 (1985). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970513: General Purpose Tranducer Cover, CIVCO Medical Instruments Co., Inc. (1997) Summary page 1.

## Indications for use
The NDUS PLUS Sterile Bag is intended to cover the motordrive during intravascular ultrasound procedures to maintain the sterile field and prevent transfer of microorganisms, body fluids and particulate material to the patient and healthcare worker.

Source page: https://510kreport.com/device/K123424
Methodology: https://510kreport.com/methodology