# K153212: Sheathes Ultrasound Probe Covers

- Pathway: 510(k) (Traditional)
- Applicant: Sheathing Technologies, Inc.
- Decided: Mar 4, 2016 after 120 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K990175 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990175: Sheathes (Non-Latex), Sterile, Sheathing Technologies, Inc. (1999) Summary page 3.

## Recalls of this device
- Nov 17, 2025 · Class II · Z-1006-2026: Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.

## Indications for use
Polyurethane probe covers are indicated during diagnostic ultrasound procedures in cases where patient sensitivity to latex is speculative. Polyurethane probe covers are contraindicated during diagnostic ultrasound procedures in cases where patients exhibit a history of hypersensitivity to the material components.

Source page: https://510kreport.com/device/K153212
Methodology: https://510kreport.com/methodology