# K150172: ACCLARENT SE Inflation Device

- Pathway: 510(k) (Special)
- Applicant: Acclarent, Inc.
- Decided: Apr 7, 2015 after 71 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: 2 generations back to K043527 (2005). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052198: Relieva Sinus Balloon Inflation Device, Acclarent, Inc. (2005) Summary page 4.

## Indications for use
The ACCLARENT® SE Inflation Device is an instrument intended to inflate, deflate and monitor pressure in balloon catheters used in sinus procedures.

Source page: https://510kreport.com/device/K150172
Methodology: https://510kreport.com/methodology