# K252007: BlineSlide

- Pathway: 510(k) (Traditional)
- Applicant: Deep Breathe, Inc.
- Decided: Oct 6, 2025 after 101 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K935595 (1995). 114 ancestors in all.
No later device cites it as a predicate yet.
0 of 115 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232501: AI Platform (AIP001), Exo, Inc. (2023) Summary page 6.

## Indications for use
The device is intended for noninvasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters of structures and function of patients aged 18 years or older with suspected disease.

Source page: https://510kreport.com/device/K252007
Methodology: https://510kreport.com/methodology