# K073041: Relieva and Relieva Acella Sinus Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Acclarent, Inc.
- Decided: Mar 11, 2008 after 134 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
Longest line of descent: 2 generations back to K043527 (2005). 2 ancestors in all.
18 later devices descend from it; 4 cite 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)
- K043527: Relieva Sinus Balloon Dilation Catheter, Exploramed Nc1, Inc. (2005) Summary page 1.
- K061903: Relieva Sinus Balloon Catheter, Acclarent, Inc. (2006) Summary page 1.

## Most influential descendants
- K111875: Relieva Spin Sinus Dilation System (2011), 7 descendants of its own
- K111254: Relieva Solo Elite Sinus Balloon Catheter (2011), 7 descendants of its own
- K090660: Airway Balloon Catheter Inflation Device (2009), 4 descendants of its own
- K143541: Relieva SpinPlus Balloon Sinuplasty System (2015), 2 descendants of its own
- K120280: Relieva Seeker Balloon Sinuplasty System (2012), 2 descendants of its own

## Indications for use
Relieva Sinus Balloon Catheter is an instrument intended to dilate sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures. For children aged 17 and under, the balloon catheter system is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures. Relieva Acella Sinus Balloon Catheter is an instrument intended to dilate sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures. For children aged 17 and under, the balloon catheter system is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K073041
Methodology: https://510kreport.com/methodology