# K041077: Imalux Oct Probe Guide

- Pathway: 510(k) (Traditional)
- Applicant: Imalux Corporation
- Decided: Jun 25, 2004 after 60 days
- Product code: KKX (Drape, Surgical, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 878.4370
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K895614 (1989). 10 ancestors in all.
10 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013721: Synthetic Polysioprene Ultrasound Transducer Cover, CIVCO Medical Instruments Co., Inc. (2001) Summary page 1.
- K990354: Endosheath, Vision-Sciences, Inc. (1999) Summary page 1.

## Most influential descendants
- K112770: Nvision Vle Imaging System, Nvision Vle Catheter (2011), 9 descendants of its own
- K120800: Nvision Vle Imaging System (2013), 6 descendants of its own
- K143678: NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory (2015), 5 descendants of its own
- K153479: NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System (2016), 2 descendants of its own
- K182616: NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System (2018), 1 descendant of its own

## Indications for use
The Imalux OCT (Optical Coherence Tomography) Probe Sheath is a sterile, single-use, protective sheath that is used as an accessory with the Imalux OCT Imaging System. The Imalux OCT Probe Sheath is intended to serve as a microbial barrier between the probe and the patient's tissue, helping to prevent the transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the probe.

Source page: https://510kreport.com/device/K041077
Methodology: https://510kreport.com/methodology