# K221206: Compass Steerable Needle

- Pathway: 510(k) (Traditional)
- Applicant: Serpex Medical, Inc.
- Decided: Aug 25, 2022 after 121 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: 6 generations back to K914181 (1991). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171232: PeriView FLEX, Olympus Surgical Technologies America (2017) Summary page 4.
- K182188: Ion Endoluminal System ; Flexision Biopsy Needle, Intuitive Surgical (2019) Summary page 4.

## Most influential descendants
- K252874: Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 (2025), 0 descendants of its own

## Indications for use
The Compass Steerable Needle is a steerable biopsy needle intended 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/K221206
Methodology: https://510kreport.com/methodology