# K130736: Blom-Singer Adjustable BI-Fianged Fistula Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Helix Medical, LLC
- Decided: Dec 17, 2013 after 274 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 K841350 (1984). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K841350: Salivary Bypass Tube, E. Benson Hood Laboratories, Inc. (1984) Summary page 1.

## Cited in the summary but kept off the family tree
- K96268: Montgomery Radiopaque Salivary Bypass Tube. Number could not be read Summary page 1.

## Indications for use
The Blom-Singere Adjustable Ri-Flanged Fistula Prosthesis is indicated for the management of hypopharyngeal fistulae. This is a short term medical device, normally intended for continuous use for not mare than 29 days. It needs periodic replacement.

Source page: https://510kreport.com/device/K130736
Methodology: https://510kreport.com/methodology