# K071845: Relieva Luma Sinus Illumination System, Model Sis-100A

- Pathway: 510(k) (Traditional)
- Applicant: Acclarent, Inc.
- Decided: Sep 28, 2007 after 85 days
- Product code: KAM (Cannula, Sinus)
- Device class: 1
- Regulation: 21 CFR 878.4800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
19 later devices descend from it; 4 cite it directly.
0 of 20 devices 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
- K043445: Relieva Sinus Guidewire. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K111763: Pathassist Light Fiber (2011), 8 descendants of its own
- K120962: Pathassist Light Fiber (2012), 7 descendants of its own
- K130503: Pathassist Led Light Fiber (2013), 6 descendants of its own
- K141916: Pathassist Led Light Fiber (2014), 5 descendants of its own
- K110158: Illuminating Sinus Seeker (2011), 3 descendants of its own

## Indications for use
The Relieva LumaTM Sinus Illumination System is intended to provide a means to access the sinus space for diagnostic and therapeutic procedures in conjunction with other nasal and sinus products. It is also intended to illuminate within and transilluminate across nasal and sinus structures.

Source page: https://510kreport.com/device/K071845
Methodology: https://510kreport.com/methodology