# K072891: Sinus Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Acclarent, Inc.
- Decided: Mar 19, 2008 after 161 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: 1 generation back to K912418 (1991). 4 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K062458: Ethmoid Sinus Spacer, Acclarent, Inc. (2006) Summary page 1.
- K951066: Rains Frontal Sinus Stent, Smith & Nephew Richards, Inc. (1995) Summary page 1.
- K050340: Micromedics Sphenoid Sinus Stent, Micromedics, Inc. (2005) Summary page 1.
- K912418: Shikani Middle Meatal Antrostomy Vent Tube, Micromedics, Inc. (1991) Summary page 1.

## Most influential descendants
- K083574: Relieva Stratus Microflow Spacer (2009), 2 descendants of its own
- K093594: Modification to Relieva Stratus Microflow Spacer (2010), 1 descendant of its own
- K110687: Relieva Stratus Pro Microflow Spacer (Frontal) (2011), 0 descendants of its own

## Indications for use
The Sinus Spacer is indicated for use as a postoperative spacer to maintain an opening to the nasal sinuses within the first 14 days following surgery. The Sinus Spacer also helps to prevent obstructions.

Source page: https://510kreport.com/device/K072891
Methodology: https://510kreport.com/methodology