# K251664: Single Use Aspiration Needle  (NA-201SX-4021); Single Use Aspiration Needle  (NA-201SX-4022)

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Jul 29, 2025 after 60 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 6.

## Indications for use
The Single Use Aspiration Needle NA-201SX-4021 is intended to be used for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree in combination with an ultrasound endoscope. The Single Use Aspiration Needle NA-201SX-4022 is intended to be used for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree in combination with an ultrasound endoscope.

Source page: https://510kreport.com/device/K251664
Methodology: https://510kreport.com/methodology