# K131745: Blom-Singer Septal Perforation Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Helix Medical, LLC
- Decided: Sep 17, 2013 after 96 days
- Product code: LFB (Button, Nasal Septal)
- Device class: U
- 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 K810738 (1981). 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)
- K013696: Silmed Nasal Septal Button, Silmed, Inc. (2001). Our reading of the summary gave K013686, FDA’s number for Kodak Directview Tabletop Cassette (Eastman Kodak Company). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Silmed Nasal Septal Button”.
- K810738: Goode Magnetic Nasal Splint, Xomed, Inc. (1981) Summary page 1.

## Indications for use
The Blom-Singer® Septal Perforation Prosthesis is indicated for the non-surgical closure of nasal septal perforations.

Source page: https://510kreport.com/device/K131745
Methodology: https://510kreport.com/methodology