# K252874: Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01

- Pathway: 510(k) (Special)
- Applicant: Serpex Medical, Inc.
- Decided: Oct 8, 2025 after 28 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: 7 generations back to K914181 (1991). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221206: Compass Steerable Needle, Serpex Medical, Inc. (2022) Summary page 5.

## Indications for use
The Compass Steerable Needle is a steerable transbronchial biopsy needle intended to be used through a compatible working channel bronchoscope or Medtronic Extended Working Channel (EWC) for the collection of tissue from the intrapulmonary regions.

Source page: https://510kreport.com/device/K252874
Methodology: https://510kreport.com/methodology