# K152109: HD-Camera HDC1000

- Pathway: 510(k) (Traditional)
- Applicant: W.O.M. World of Medicine GmbH
- Decided: Oct 13, 2015 after 76 days
- Product code: FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K024291: Arthrex Continuous Wave Iii Arthoscopy Pump, Model AR-6475, Arthrex, Inc. (2003). Our reading of the summary gave K024291, FDA’s number for Arthrex Continuous Wave Iii Arthoscopy Pump, Model AR-6475 (Arthrex, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “OVS1 Video System”. Kept off the family tree. Summary page 5.

## Indications for use
The HD-Camera HDC1000 is intended to be used during diagnostic and operative endoscopic procedures to provide illumination and visualization of body cavities, hollow organs and canals and to allow for image recording and documentation. The HD-Camera HDC1000 is indicated for use with compatible rigid or flexible endoscopes and other video equipment and endoscopic accessories.

Source page: https://510kreport.com/device/K152109
Methodology: https://510kreport.com/methodology