# K052198: Relieva Sinus Balloon Inflation Device

- Pathway: 510(k) (Traditional)
- Applicant: Acclarent, Inc.
- Decided: Aug 31, 2005 after 19 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.
6 later devices descend from it; 2 cite it directly.
0 of 8 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 2.

## Most influential descendants
- K090660: Airway Balloon Catheter Inflation Device (2009), 4 descendants of its own
- K150951: aeris Balloon Dialation Catheter (2015), 1 descendant of its own
- K231818: METIC™- Airway Balloon Catheter (2023), 0 descendants of its own
- K153484: Dillard Airway Dilatation System (2016), 0 descendants of its own
- K150172: ACCLARENT SE Inflation Device (2015), 0 descendants of its own

## Indications for use
The Relieva Sinus Balloon Inflation Device is recommended for use to inflate the balloon, monitor the pressure within the balloon and deflate the balloon while performing balloon dilation procedures of the sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K052198
Methodology: https://510kreport.com/methodology