# K042438: Superdimension/Bronchus

- Pathway: 510(k) (Traditional)
- Applicant: Superdimension, Ltd.
- Decided: Nov 8, 2004 after 61 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K926514 (1993). 11 ancestors in all.
73 later devices descend from it; 5 cite it directly.
6 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022354: Ultraguide CTG 2000SA, Ultraguide, Ltd. (2002) Summary page 1.
- K982323: Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for Bronchial Use, Olympus America, Inc. (1998) Summary page 1.
- K023984: Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 Series, The Olympus Optical Co. (2003) Summary page 1.

## Most influential descendants
- K052260: Superdimension/Bronchus 4.1 (2005), 56 descendants of its own
- K052852: Superdimension/Bronchus Premium (2005), 55 descendants of its own
- K062315: Superdimension/Bronchus Premium 2 (2006), 54 descendants of its own
- K071473: Modification to Superdimension/Bronchus Premium 2 (2007), 53 descendants of its own
- K080271: Inreach System (2008), 52 descendants of its own

## Recalls of this device
- Nov 29, 2006 · Not classified · Z-0666-2007: The action is being taken in response to certain incidents that have been reported to the company, one of which concerned an adverse event in which a patient incurred a pneumothorax during a procedure

## Indications for use
Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools in the pulmonary tract. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.

Source page: https://510kreport.com/device/K042438
Methodology: https://510kreport.com/methodology