# K061903: Relieva Sinus Balloon Catheter

- Pathway: 510(k) (Special)
- Applicant: Acclarent, Inc.
- Decided: Aug 18, 2006 after 44 days
- Product code: LRC (Instrument, Ent Manual Surgical)
- Device class: 1
- Regulation: 21 CFR 874.4420
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K043527 (2005). 1 ancestor in all.
49 later devices descend from it; 3 cite it directly.
0 of 51 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.

## 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
- K093007: Entellus Medical Balloon Device (2010), 41 descendants of its own
- K102003: Xpress Balloon Device (2010), 36 descendants of its own
- K112506: Xpress Multi-Sinus Dilation Tool (2011), 21 descendants of its own
- K121174: Xpress Multi-Sinus Dilation Tool (2012), 20 descendants of its own
- K073041: Relieva and Relieva Acella Sinus Balloon Catheter (2008), 18 descendants of its own

## Indications for use
To provide a means to access the sinus space and to dilate the sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K061903
Methodology: https://510kreport.com/methodology