# K981069: Ultra-Cover PU-Transducer Cover

- Pathway: 510(k) (Traditional)
- Applicant: International Medical Products B.V.
- Decided: Sep 23, 1998 after 183 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
Protective cover placed over diagnostic ultrasound-transducer/probe/scanhead instruments. The cover allows use of the transducer in scanning procedures for body surface, endocavity, and intra-operative diagnostic ultra-sound, while helping to prevent transfer of micro-organisms, body-fluids, and material to the patient and healthcare worker during reuse of the transducer. Ultra-Cover PU-transducer covers are furnished sterile & non-sterile; single use patient/procedure, disposable The intended use and indications for use place Ultra-Cover PU-transducer covers in device body contact categories as follows: a) surface devices, intact skin/mucosal membranes/breached surfaces, limited contact duration. 24 hours) b) external communicating devices, blood path indirect/tissue communicating, limited contact duration (≤24 hours).

Source page: https://510kreport.com/device/K981069
Methodology: https://510kreport.com/methodology