# K251478: ClearTip TBNA Type

- Pathway: 510(k) (Traditional)
- Applicant: Finemedix Co., Ltd.
- Decided: Apr 16, 2026 after 338 days
- Product code: KTI (Bronchoscope Accessory)
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K894632 (1989). 59 ancestors in all.
No later device cites it as a predicate yet.
1 of 60 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190239: Single Use Aspiration Needle, Olympus Medical Systems Corp. (2019) Summary page 5.

## Indications for use
The ClearTip TBNA Type is intended for Ultrasonically Guided Fine Needle Aspiration, (FNA) of submucosal and extraluminal lesions of the Tracheobronchial Tree.

Source page: https://510kreport.com/device/K251478
Methodology: https://510kreport.com/methodology