# K946300: Dopplex Surgical Probes

- Pathway: 510(k) (Traditional)
- Applicant: Hne Healthcare, Inc.
- Decided: Jul 26, 1995 after 210 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
No predicates in its family tree.
2 later devices descend 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K032315: IOP8 Intra Operative Probe (2004), 1 descendant of its own
- K201425: Disposable Intraoperative Probe (DIOP8) (2021), 0 descendants of its own

Source page: https://510kreport.com/device/K946300
Methodology: https://510kreport.com/methodology