# K110093: Superdimension Marker Delivery Kit

- Pathway: 510(k) (Special)
- Applicant: Superdimension, Inc.
- Decided: Feb 11, 2011 after 30 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- 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 K926514 (1993). 20 ancestors in all.
4 later devices descend from it; 1 cites it directly.
1 of 25 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071473: Modification to Superdimension/Bronchus Premium 2, Superdimension, Ltd. (2007) Summary page 1.
- K092365: Inreach System, Model AAS00161-02, Superdimension, Ltd. (2009) Summary page 1.
- K102604: I-Logic Inreach System, Superdimension, Ltd. (2010) Summary page 1.

## Most influential descendants
- K112051: Lungpoint Planning and Virtual Bronchoscopic Navigation (VBN) Software (2011), 3 descendants of its own
- K181892: Ziostation2 (2018), 1 descendant of its own
- K200315: Ziostation2 (2020), 0 descendants of its own
- K133385: Lungpoint Atv Planning and Navigation Software (2014), 0 descendants of its own

## Indications for use
Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.

Source page: https://510kreport.com/device/K110093
Methodology: https://510kreport.com/methodology