# K221302: Recon Steerable Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Serpex Medical, Inc.
- Decided: Aug 15, 2022 after 102 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- 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: 3 generations back to K931154 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172955: LungVision Tool, Bodyvision Medical, Ltd. (2018) Summary page 4.

## Indications for use
The Recon Steerable Sheath is an extended working channel intended to be used with a compatible bronchoscope to guide endotherapy accessories to the target area within the respiratory system.

Source page: https://510kreport.com/device/K221302
Methodology: https://510kreport.com/methodology