# K201425: Disposable Intraoperative Probe (DIOP8)

- Pathway: 510(k) (Traditional)
- Applicant: Huntleigh Healthcare Limited
- Decided: Feb 19, 2021 after 266 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: 2 generations back to K946300 (1995). 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)
- K032315: IOP8 Intra Operative Probe, Huntleigh Healthcare, Inc. (2004) Summary page 5.

## Recalls of this device
- Feb 11, 2022 · Class II · Z-0960-2022: Faceplate may become detached from the probe body.

## Indications for use
The DIOPS surgical Doppler is indicated for use by qualified healthcare practitioners in a sterile condition in the operating theatre for the assessment of vascular blood flow by direct application to the vessel wall.

Source page: https://510kreport.com/device/K201425
Methodology: https://510kreport.com/methodology