# K190239: Single Use Aspiration Needle

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Dec 10, 2019 after 307 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: 12 generations back to K894632 (1989). 58 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 61 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163469: ViziShot 2 FLEX, Olympus Surgical Technologies America (2017) Summary page 5.

## Most influential descendants
- K251478: ClearTip TBNA Type (2026), 0 descendants of its own
- K251664: Single Use Aspiration Needle  (NA-201SX-4021); Single Use Aspiration Needle  (NA-201SX-4022) (2025), 0 descendants of its own

## Indications for use
This instrument has been designed to be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree.

Source page: https://510kreport.com/device/K190239
Methodology: https://510kreport.com/methodology