# K253846: Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe) (SPA-C02); Disposable Sterile Steep Pulse Probe (NPA-DJ01); Probe connection line (NPA-LX-02)

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou Ruidi Biotechnology, Ltd.
- Decided: Aug 12, 2026 after 253 days
- Product code: OAB (Low Energy Direct Current Thermal Ablation System)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K942299 (1995). 50 ancestors in all.
No later device cites it as a predicate yet.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183385: NanoKnife System, Angiodynamics (2019) Summary page 6.

## Indications for use
Steep Pulse Ablation Instrument is indicated for the surgical ablation of soft tissue.

Source page: https://510kreport.com/device/K253846
Methodology: https://510kreport.com/methodology