# K032315: IOP8 Intra Operative Probe

- Pathway: 510(k) (Traditional)
- Applicant: Huntleigh Healthcare, Inc.
- Decided: Nov 18, 2004 after 479 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: 1 generation back to K946300 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K946300: Dopplex Surgical Probes, Hne Healthcare, Inc. (1995) Summary page 2.

## Most influential descendants
- K201425: Disposable Intraoperative Probe (DIOP8) (2021), 0 descendants of its own

## Indications for use
The IOP8 is a passive, self contained, sterilizable, reusable, Pulsed Doppler pencil probe. It enables easy detection of blood flow in vessels of varying diameters, providing evidence of success in vascular reconstructive procedures, including skin grafting. The IOP will be located on the surface of vessels to assist in the assessment of blood flow. The probe will not be inserted into vessels and does not contact circulating blood.

Source page: https://510kreport.com/device/K032315
Methodology: https://510kreport.com/methodology